Health-Related Quality of Life in Cancer Clinical Trials

The Clinical Trials Referral Resource thatappeared in the April issue of ONCOLOGY began a series on health-related qualityof life (HRQOL). Part I of this series, which concludes this month, focuses onHRQOL questions in cancer treatment trials. Part II (on investigator-initiatedHRQOL research) and part III (on HRQOL research as part of cancer preventiontrials) will appear in upcoming issues. Information about these studies can beobtained from the contacts listed for each trial or from Edward L. Trimble, MD,MPH, at the Cancer Therapy Evaluation Program (CTEP), trimble@ctep.nci.nih.govor (301) 496-1196.

Clinical Trials Referral Resource is designed to serve as a ready reference for oncologists to help identify clinical trials that might be suitable for their patients. We hope it will also enhance accrual to clinical trials by informing practicing oncologists of ongoing protocols. Currently in the United States less than 10% of eligible adult patients are entered into clinical trials. The result is a delay in answering important therapeutic and scientific questions and disseminating therapeutic advances to the general oncology community.

It should be emphasized that including a specific trial does not imply that it is more important than another trial. Among the criteria for selection are that the trial is addressing an important question and is not expected to close in the immediate future (less than 1 year), and that initial staging or laboratory tests required for patient eligibility are widely practiced and available. Information on other protocols can be accessed via Physician’s Data Query (PDQ).*

We emphasize that this is an attempt to encourage referral of patients to these trials. We are specifically not soliciting additional members for the cooperative groups, nor are we suggesting how practicing oncologists should be treating patients who are not in a study.

This month’s installment of Clinical Trials Referral Resource is devoted to studies regarding health-related quality of life for cancer patients.

For patient entry information, see the individual trials.

* PDQ is a comprehensive database service provided by the National Cancer Institute’s International Cancer Information Center and Office of Cancer Communications for retrieval of cancer treatment information, including peer-reviewed statements on treatment options, supportive care, screening, and prevention; and an international clinical trials registry. For more information on PDQ, Internet access is available at http://cancernet.nci.nih.gov/pdqfull.html, or contact the Cancer Information Service offices (1-800-4-CANCER).

Group or Lead Group: GOG
Protocol Number: GOG-9902 (active; phase: other; adult)
Title: Quality of Life of Gynecologic Cancer Survivors
QOL Instruments/End Points:Medical Outcomes Study Short Form 36:Activities of daily living: walking, climbing, stairs, bathing, dressing, andperformance of physical activities, problems and interference with dailyactivities, how you feel, perceived health

Center for Epidemiological Studies—Depression: Depression, restless sleep, crying spells, sadness, feel disliked

Stressful Life Events: Personal meaning of stress from work lay off, retirement, marriage, marital problems, divorce, death or hospitalization of spouse, birth/adoption of child, death of family member/friend, jail, financial difficulties

QOL—Cancer Survivors: Physical well-being with respect to fatigue, appetite changes, aches/pains, constipation, nausea, mentrual/fertility changes, overall health; psychological well-being including difficulty of coping, happiness, in control, satisfaction of life, concentration, feeling of usefulness, changes in appearance, changes in self concept; distress of diagnosis, treatments, time after completion of treatment, anxiety, depression; fear of future tests, second cancer, recurrence of cancer, metastasis; social concerns of distress to family, adequacy of support received, interference with personal relationships, sexuality, interference with employment or activities at home

Functional Assessment of Cancer Therapy/GOG—Neurotoxicity: Hand/feet numbness/tingling, joint pain, muscle cramps, weakness, trouble hearing, dexterity, walking ability

Impact of Event Scale: Feelings, thoughts, memories, and dreams about having cancer

Duke-UNC Functional Social Support Questionaire: Assesses whether amount of family/social support is as much as patient would like for care, love/affection, talk, invitations, advice, help when sick in bed

Protocol Status: Active
Contact: Lari B. Wenzel, Gynecologic Oncology Group, (949) 824-3926; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: GOG
Protocol Number: GOG-9905 (approved; phase: other; adult)
Title: Assessing Economic Outcomes in Women With Stage III Ovarian CancerTreated With Intravenous Paclitaxel and Cisplatin vs IV Paclitaxel, IP Cisplatinand IP Paclitaxel on GOG #172: A Feasibility Study of Assessing Costs andMedical Resource Use
QOL Instruments/End Points:Functional Assessment of Cancer Therapy—Ovarian:Physical, social/family, emotional and functional well-being; additionalconcerns

GOG—neurotoxicity subscale: Short-term and long-term symptoms of neurotoxicity

Protocol Status: In review
Contact: Martee L. Hensley, MD, (212) 639-6555

Participating Institution/Group: M. D. Anderson CancerCenter (MDA) and ECOG; Multicenter
Protocol Number: NCI-T97-0069 (active; phase III; adult)
Title: Phase III Randomized Adjuvant Study of Hormonal Therapy inSurgically Treated Prostate Cancer Patients at High Risk of Recurrence
QOL Instruments/End Points: Medical Outcomes Study Short Form 36:Overall health rating; limitations to physical activities; problems at work orin regular daily activity related to physical health or emotional problems;interferences with social activities; pains and interference with normal work;emotional state

Profile of Mood States: Assesses mood states: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-intertia, and confusion-bewilderment

UCLA Sexual Function Scale: Quality and frequency of erections, intercourse, and sexual function

Dyadic Adjustment Scale (Spanier): Marital stress: satisfaction, cohesion, consensus, expression of affection

Southwest Oncology Group (SWOG) Treatment-Specific Symptom Checklist: Diarrhea, crampy/abdominal pain, tenderness and urgency with bowel movements, urine flow, gas pain, hot flashes, breast tenderness, breast swelling or enlargement

Protocol Status: Active
Contact: Curtis A. Pettaway, University of Texas - MD Anderson CancerCenter, (713) 792-3250
Latest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: North American Brain Tumor Consortium(NABTC); Consortium
Protocol Number: NABTC-9905 (active; phase II; adult)
Title: Phase II Study of Fenretinide in Patients With RecurrentMalignant Glioma
QOL Instruments/End Points:M. D. Anderson Symptom Inventory (MDASI) Core Items: Assesses symptoms in last24 hrs for eyesite, fatigue (tiredness), nausea or vomiting, disturbed sleep,remembering things, lack of appetite, drowsy, skin dryness, a dry mouth, sad,headache, general activity, work (including work around house), mood, sexualrelations, relations with other people, walking, enjoyment of life

Vision Questionnaire: Difficulties with bumping into objects,seeing less well in evening or low light, driving at sunset/dusk, distinguishingoutlines in dim lighting, being dazzled by passing from a dim to strongly litroom; notice change in adaptation to changing light levels

Protocol Status: Active
Contact: Vinay K. Puduvalli, North American Brain Tumor Consortium, (713)794-1286; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: New Approaches to Brain Tumor Therapy(NABTT)
Protocol Number: NABTT-101-9601 (approved; phase I; adult)
Title: Phase I Study of Polifeprosan 20 With Carmustine Implant(GLIADEL) in Patients With Recurrent Malignant Glioma
QOL Instruments/End Points:Medical Outcomes Study ShortForm 36: Overall health rating; limitations to physical activities; problems atwork or in regular daily activity related to physical health or emotionalproblems; interferences with social activities; pains and interference withnormal work; emotional state

Karnofsky Performance Scale: Global functioning in terms ofdegree of mobility, ability to maintain employment, live at home and care foroneself

Protocol Status: Active
Contact: Alessandro Olivi, Johns Hopkins Oncology Center, (410)550-0465; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: North Central Cancer Treatment Center(NCCTG)
Protocol Number: NCCTG-N9923 (active; phase I/II; adult)
Title: Phase I/II Study of Topotecan and Paclitaxel Preceding andFollowing High Dose Thoracic Radiotherapy With Concurrent Cisplatin, Etoposide,and Amifostine in Patients With Limited Stage Small Cell Lung Cancer
QOL Instruments/End Points:NCCTG Uniscale: Lowest quality ® highest quality
Protocol Status: Active
Contact: Scott Okuno, North Central Cancer Treatment Group, (507)284-2511; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: NCCTG
Protocol Number: NCCTG-963255 (active; phase II; adult)
Title: Phase II Randomized Study of Irinotecan for Refractory MetastaticBreast Cancer
QOL Instruments/End Points:Functional Assessment of CancerTherapy—Breast: Physical, social/family, emotional and functional well-being;additional concerns
Protocol Status: Active
Contact: Edith A. Perez, North Central Cancer Treatment Group, (904)953-7283; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: NCCTG
Protocol Number: NCCTG-98-72-51 (active; phase II; adult)
Title: A Phase II Trial of Pre-Irradiation Chemotherapy WithBCNU, Cisplatin, and Oral Etoposide Combined With Radiation Therapy in theTreatment of Grade 3 Astrocytoma (Anaplastic Astrocytoma)
QOL Instruments/End Points:ECOG Performance Score: Physicalfunction

Epworth Sleepiness Scale: Excessive daytime somnolescence

Profile of Mood States: Assesses mood states: tension-anxiety,depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment

Symptom Distress Scale: Overall level of fatigue, insomnia,pain, concentration and outlook

Functional Assessment of Cancer Therapy—Brain and LinearAnalogic Scale: Overall QOL; physical, intellectual, emotional, social, andspiritual well-being; additional concerns

Protocol Status: In review
Contact: Jan C. Buckner, MD, (507) 284-3559

Group or Lead Group: NCCTG
Protocol Number: NCCTG-N9941 (active; phase II; adult)
Title: Phase II Study of Docetaxel and Irinotecan in Patients WithAdvanced Adenocarcinoma of the Lower Esophagus, Esophagogastric Junction, orGastric Cardia
QOL Instruments/End Points:NCCTG Dysphagia Questionnaire: Difficulties with swallowing

NCCTG Patient Anorexia Questionnaire: Appetite, food intake,feeling about weight status, nausea, vomiting, effects of study medications

NCCTG Patient Swallowing Scale: Can’t swallow ® normal

Protocol Status: Active
Contact: Aminah Jatoi, North Central Cancer Treatment Group, (507)284-2511; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: NCCTG
Protocol Number: NCCTG-N0031 (active; phase II)
Title: Phase II Study of Topical Ceramide Cream in Women With CutaneousBreast Cancer
QOL Instruments/End Points:Functional Assessment of CancerTherapy—Breast: Physical, social/family, emotional and functional well-being;additional concerns
Protocol Status: Active
Contact: Aminah Jatoi, North Central Cancer Treatment Group, (507)284-2511; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: NCCTG
Protocol Number: NCCTG-N0022 (approved; phase II; adult [³ 65years])
Title: Phase II Study of Oral Vinorelbine in Elderly Patients With StageIIIB or IV Non-Small Cell Lung Cancer
QOL Instruments/End Points: Lung Cancer Symptom Scale:Appetite, fatigue, coughing, shortness of breath, blood in sputnum, pain,overall symptoms, affects on normal activities, overall QOL today

NCCTG Uniscale: Lowest quality ® highest quality

Protocol Status: Active
Contact: Aminah Jatoi, North Central Cancer Treatment Group, (507) 284-2511; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: NCCTG
Protocol Number: NCCTG-N0074 (approved; phase II; adult)
Title: Phase II Study of ZD 1839 in Patients With GlioblastomaMultiforme
QOL Instruments/End Points:Linear Analog Scale: Physical,emotional, spiritual, intellectual, and overall well-being

Epworth Sleepiness Scale: Chance of dozing while sitting andreading, watching TV, sitting inactive in a public place, as a passenger in acar for an hour without a break, lying down to rest in the afternoon, sittingand talking to someone, sitting quietly after lunch without alcohol, in a carwhile stopped a few minutes in traffic

Profile of Mood Status: Assesses mood states: tension-anxiety,depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, andconfusion-bewilderment

Symptoms Distress Scale: Nausea frequency, nausea distress,appetite, insomnia, pain frequency, pain distress, fatigue, bowel pattern,concentration, appearance, breathing, outlook, cough

Functional Assessment of Cancer Therapy—Brain (FACT-BR):Physical, social/family, emotional and functional well-being, plus additionalconcerns (concentration, seizures, memory, frustration, fear of seizure, vision,independence, hearing, finding right words, expression of thoughts, change ofpersonality, ability to make decisions and take responsibility, contribution totoxicity, putting thoughts together, help in self care, put thoughts intoaction, reading, writing, driving)

Protocol Status: Active
Contact: Joon H. Uhm, North Central Cancer Treatment Group, (507) 284-3559; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: NCCTG; Intergroup
Protocol Number: INT-0146 (active; phase III; adult)
Title: NCI HIGH PRIORITY CLINICAL TRIAL --- Phase III Randomized Study ofLaparoscopic-Assisted Colectomy vs Open Colectomy for Colon Cancer
QOL Instruments/End Points:Symptom Distress Scale: Nauseafrequency, nausea distress, appetite, insomnia, pain frequency, pain distress,fatigue, bowel pattern, concentration, appearance, breathing, outlook, cough

QOL Index (Utilities): Main activitiy, ability to function in daily living, perceived state of health, support received from others, oulook on life, overall rating

Protocol Status: Active
Contact: Thomas Julian, National Surgical Adjuvant Breast and Bowel Project,(412) 359-8229; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: NCCTG; Intergroup
Protocol Number: JMA17 (active; phase III; adult)
Title: A Phase III Randomized Double Blind Study of Letrozole VersusPlacebo in Women With Primary Breast Cancer Completing Five or More Years ofAdjuvant Tamoxifen
QOL Instruments/End Points:SF-36 Health Status Survey: Overallhealth status, physical limitations, and problems with work or other dailyactivities, social activity; pain and interference with normal work; emotionalfeelings

Menopause-Specific QOL Questionnaire: Menopause-related symptoms including hot flushes, sweating, memory, depression, impatience aching muscles/joints, flatulence, fatigue, insomnia, decreased strength, lack of energy, weight gain, changes in appearance, frequent urination, change in sexual desire, intimacy

ECOG Performance Scale: Physical activity

Protocol Status: In review
Contact: James N. Ingle, MD, (507) 284-4137

Group or Lead Group: NCCTG
Protocol Number: NCCTG-N9841 (active; phase III; adult)
Title: Phase III Randomized Study of Irinotecan Versus Oxaliplatin,Fluorouracil, and Leucovorin Calcium in Patients With Advanced Colorectal CancerPreviously Treated With Fluorouracil
QOL Instruments/End Points: NCCTG Uniscale: Lowest quality ®highest quality

Symptom Distress Scale: Overall level of fatigue, insomnia, pain, concentration, and outlook

Protocol Status: Active
Contact: Henry Clement Pitot, North Central Cancer Treatment Group, (507)284-4718; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: NCCTG
Protocol Number: NCCTG-972451 (active; phase III; adult)
Title: Phase III Randomized Study of Oral Carboxyamidotriazole inPatients With Advanced Non-Small Cell Lung Cancer
QOL Instruments/End Points:Functional Assessment of Cancer Therapy-Lung:Physical, social/family, emotional, and functional well-being; additionalconcerns

NCCTG Uniscale: Lowest quality ® highest quality

Protocol Status: Active
Contact: Edith A. Perez, MD, North Central Cancer Treatment Group, (904)953-7283 (CTSU Investigators: see footnote)*; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

* Cancer Trials Support Unit (CTSU)investigators with scientific questions about this trial should contact theprincipal investigator at the sponsoring Cooperative Group. CTSU investigatorsinterested in enrolling patients on this trial through the CTSU should contactthe CTSU General Information line for further information at (888) 823-5923 or ctsucontact@westat.com

Group or Lead Group: NCCTG
Protocol Number: NCCTG-N9741 (active; phase III; adult)
Title: Phase III Randomized Study of Combinations of Oxaliplatin,Fluorouracil, Leucovorin Calcium, and Irinotecan as Initial Therapy in PatientsWith Advanced Adenocarcinoma of the Colon and Rectum
QOL Instruments/End Points: Symptom Distress Scale: Overall levelof fatigue, insomnia, pain, concentration, and outlook

NCCTG Uniscale: Lowest quality ® highest quality

Protocol Status: Active
Contact: Richard M. Goldberg, North Central Cancer Treatment Group, (507)266-0029; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: National Cancer Institute of Canada(NCIC); Intergroup
Protocol Number: JBR10 (active; phase III; adult)
Title: A Phase III Prospective Randomized Study of Adjuvant ChemotherapyWith Vinorelbine and Cisplatin in Completely Resected Non-Small-Cell LungCancer With Companion Tumor Marker Evaluation
QOL Instruments/End Points:EORTC Core Questionnaire (QLQ-C30 + 3): Generalphysical symptoms, physical functioning, fatigue/malaise, social functioning,psychological stress (specific end points similar to QLQ-C30 instrument: see #42below)
Protocol Status: In review
Contact: Timothy Winton, MD, (416) 340-3786

Group or Lead Group: NCIC; Intergroup
Protocol Number: JPR.7 (active; phase III; adult)
Title: A Phase III Randomized Trial Comparing Intermittent vs ContinuousAndrogen Suppression for Patients With Prostate-Specific-Antigen Progressionin the Clinical Absence of Distant Metastases Following Radiotherapy forProstate Cancer
QOL Instruments/End Points: EORTC Core Questionnaire (QLQ-C30): Generalphysical symptoms, physical functioning, fatigue/malaise, social functioning,psychological stress; specific end points for strenuous or normal physicalactivities, leisure activities, short of breath, pain, need for rest, weakness,appetite, nausea, vomiting, constipation, diarrhea, concentration, tense, worry,irritable, depressed, memory, interference with family life or socialactivities, overall health

ECOG Performance Scale: Physical activity

Nutrition Survey: Types, amounts, and frequency of consumption of different foods and beverages; physical activities

Protocol Status: In review
Contact: Juanita M. Crook, MD, (416) 946-2000 (CTSU Investigators: seefootnote)*

Group or Lead Group: NCIC; Intergroup
Protocol Number: T94-0110 (active; phase III; adult)
Title: Randomized Trial Comparing Total Androgen Blockade vs TotalAndrogen Blockade Plus Pelvic Irradiation in Clinical Stage T3-4, N0, M0Adenocarcinoma of the Prostate
QOL Instruments/End Points: EORTC Core Questionnaire 33: Strenuousto light physical activities, shortness of breath, pain, need for rest,difficulty sleeping, appetite, nausea, vomiting, constipation, diarrhea,tension, worry, depression, limitations or interference with home activites,work, family life and social activities, finanicial difficulties, overallphysical condition/health/QOL, emotional state, social enjoyment, bladdercontrol, rectal bleeding/pain, hot flashes, sex life

Functional Assessment of Cancer Therapy—Prostate: Overall QOL; pain and fatigue; physical, social, emotional and functional wellbeing; additional concerns about prostate cancer

Protocol Status: In review
Contact: Padraig Warde, MD, (416) 946-2122

Group or Lead Group: National Surgical Adjuvant Breastand Bowel Project (NSABP)
Protocol Number: NSABP-B-30 (active; phase III; adult)
Title: Phase III Randomized Study of Adjuvant Doxorubicin andCyclophosphamide Followed by Docetaxel Versus Doxorubicin and Docetaxel VersusDoxorubicin, Docetaxel, and Cyclophosphamide in Women With Breast Cancer andPositive Axillary Nodes
QOL Instruments/End Points:Functional Assessment of Cancer Therapy-Breast(CELLA): Physical, social/family, emotional and functional well-being;patient/physician relationship; additional concerns for breast cancer patients

Symptom Inventory: Frequency and severity of symptoms potentially associated with treatment regimen

Medical Outcomes Study—Vitality Scale: Detects common but less specific side effects of cancer therapy such as fatigue and lack of energy

QOL Rating Scale—NSABP: Overall QOL summary

Protocol Status: Active
Contact: Sandra M. Swain, National Surgical Adjuvant Breast and BowelProject, (301) 496-4916 (CTSU Investigators: see footnote)*; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

* Cancer Trials Support Unit (CTSU)investigators with scientific questions about this trial should contact theprincipal investigator at the sponsoring Cooperative Group. CTSU investigatorsinterested in enrolling patients on this trial through the CTSU should contactthe CTSU General Information line for further information at (888) 823-5923 or ctsucontact@westat.com

Group or Lead Group: Radiation Therapy Oncology Group(RTOG)
Protocol Number: RTOG-9909 (approved; phase II; adult)
Title: Phase II Study of Adjuvant Monoclonal Antibody 11D10 Anti-IdiotypeVaccine and Monoclonal Antibody 3H1 Anti-Idiotype Vaccine With Radiotherapy inPatients With Completely Resected Stage II or IIIA Non-Small Cell Lung Cancer
QOL Instruments/End Points: Patient Swallowing Diary: (No furtherinformation available)
Protocol Status: Active
Contact: Benjamin Movsas, Radiation Therapy Oncology Group, (215) 728-5304; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: RTOG
Protocol Number: RTOG-BR-0023 (approved; phase II; adult)
Title: Phase II Study of Accelerated Radiotherapy With ConformalStereotactic Radiotherapy Boost Followed by Carmustine in Patients WithSupratentorial Glioblastoma Multiforme
QOL Instruments/End Points:Neurologic Function Status: Neurologicsymptoms on scale from none to severe based on activity at home/work and amountof assistance required

Karnofsky Performance Scale: Global functioning in terms of degree of mobility, ability to maintain employment, live at home, and care for oneself

Protocol Status: Active
Contact: Robert Michael Cardinale, Radiation Therapy Oncology Group, (804)828-7232 ext 84; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: RTOG
Protocol Number: RTOG-E-0113 (approved; phase II; adult)
Title: Phase II Randomized Study of Cisplatin, Paclitaxel, and ConcurrentRadiotherapy With or Without Fluorouracil in Patients With Previously UntreatedCarcinoma of the Esophagus or Gastroesophageal Junction
QOL Instruments/End Points: Functional Assessment of Cancer Therapy—Headand Neck (version 2): Physical and functional well-being scale, additionalconcerns for head and neck cancer therapy (difficulties in subjective assessmentdue to effects of therapeutic agents on speaking, etc)
Protocol Status: Active
Contact: Jaffer A. Ajani, Radiation Therapy Oncology Group, (713) 792-2828; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: RTOG; Intergroup
Protocol Number: INT-0149 (active; phase III; not specified)
Title: Phase III Randomized Study of Radiotherapy With or WithoutIntensive Procarbazine, Lomustine, and Vincristine (PCV) in Patients WithUnifocal or Multifocal, Supratentorial, Pure or Mixed AnaplasticOligodendroglioma
QOL Instruments/End Points: Karnofsky Performance Scale: Globalfunctioning in terms of degree of mobility, ability to maintain employment, liveat home, and care for oneself

Neurologic Function Status: Neurologic symptoms and affects on activity at work/home

Protocol Status: Active
Contact: Walter John Curran, Jr., Radiation Therapy Oncology Group, (215)955-6700; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: RTOG
Protocol Number: RTOG-9408 (active; phase III; adult)
Title: Phase III Randomized Study of Radiotherapy With or WithoutNeoadjuvant Flutamide Plus Goserelin or Leuprolide in Patients With GoodPrognosis, Locally Confined Adenocarcinoma of the Prostate
QOL Instruments/End Points:Sexual Adjustment Questionnaire (use ofquestionnaire was discontinued
6/20/97): Not available
Protocol Status: Active
Contact: David G. McGowan, Radiation Therapy Oncology Group, (780) 432-8755; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: RTOG
Protocol Number: RTOG-9801 (active; phase III; adult)
Title: Phase III Randomized Study of Amifostine Mucosal Protection inPatients with Favorable Performance Inoperable Stage II, IIIA, or IIIB Non-SmallCell Lung Cancer Receiving Sequential Induction and Concurrent HyperfractionedRadiotherapy with Paclitaxel and Carboplatin
QOL Instruments/End Points:EORTC Core Questionnaire (C30):General physical symptoms, physical functioning, fatigue/malaise, socialfunctioning, psychological stress

EORTC QOL Questionnaire—Lung (LC-13): Asks additional questions specific to lung cancer and treatment-related symptoms

Protocol Status: Active
Contact: Benjamin Movsas, Radiation Therapy Oncology Group, (215) 728-5304; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: RTOG
Protocol Number: RTOG-9903 (active; phase III; adult)
Title: Phase III Randomized Study of Radiotherapy With or Without EpoetinAlfa in Anemic Patients With Squamous Cell Carcinoma of the Head and Neck
QOL Instruments/End Points: None available
Protocol Status: Active
Contact: Mitchell Machtay, Radiation Therapy Oncology Group, (215) 662-2428; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: RTOG
Protocol Number: RTOG-BR-0018 (active; phase: other)
Title: Study of Neurocognitive Evaluation Following Radiotherapy inPatients With Brain Metastases
QOL Instruments/End Points:Profile of Mood States—Short Form: Assessesmood states: tension-anxiety, depression-dejection, anger-hostility,vigor-activity, fatigue-intertia, and confusion-bewilderment
Protocol Status: Active
Contact: William F. Regine, Radiation Therapy Oncology Group, (859) 323-6486; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: Southwest Oncology Group (SWOG)
Protocol Number: S0006 (approved; phase II; adult)
Title: Phase II Trial of Herceptin, Paclitaxel and Carboplatin inAdvanced or Metastatic Chemonaive Non-Small-Cell Lung Cancer (NSCLC)
QOL Instruments/End Points:Zubrod Performance Scale: Assessescapability of self-care on 0-4 scale from asymptomatic to symptomatic tocompletely disabled
Protocol Status: In review
Contact: Marj Godfrey, Coordinator, (210) 677-8808

Group or Lead Group: SWOG
Protocol Number: SWOG-S0031 (active; phase II; adult)
Title: Phase II Study of ZD 1839 in Patients With Advanced TransitionalCell Carcinoma of the Urothelium
QOL Instruments:Zubrod Performance Scale: Assesses capability ofself-care on 0-4 scale from asymptomatic, to symptomatic, to completelydisabled
Protocol Status: Active
Contact: Daniel P. Petrylak, Southwest Oncology Group, (212) 305-1731 (CTSUInvestigators: see footnote)*; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

* Cancer Trials Support Unit (CTSU)investigators with scientific questions about this trial should contact theprincipal investigator at the sponsoring Cooperative Group. CTSU investigatorsinterested in enrolling patients on this trial through the CTSU should contactthe CTSU General Information line for further information at (888) 823-5923 or ctsucontact@westat.com

Group or Lead Group: SWOG; Intergroup
Protocol Number: INT-0162 (active; phase III; adult)
Title: Phase III Randomized Study of Intermittent Versus ConstantCombined Androgen Deprivation (Bicalutamide and Goserelin) in Patients WithStage IV Prostate Cancer Responsive to Such Therapy
QOL InstrumentsEnd Points: SWOG Performance Status: Physicalactivity

Medical Outcomes Study—Short Form 36 (SF-36): Vitality/fatigue

Mental Health Inventory (SF-36): Emotional functioning

Symptom Distress Scale: Overall level of fatigue, insomnia,pain, concentration (outlook and cough omitted for this trial);treatment-specific symptoms include body image, breast swelling, breasttenderness, crampy/abdominal pain, proctitis, urine flow, incontinence, hotflashes, and ability to have erection

Medical Outcome—Short Form 20 (SF-20): Role functioning scale,social functioning

Linear Analog Self-Assessment (LASA Uniscale): Global perceptionof QOL, health-related QOL rating

Protocol Status: Active
Contact: Maha Hadi A. Hussain, Southwest Oncology Group, (313) 745-2357; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: SWOG
Protocol Number: SWOG-S9916 (active; phase III; adult)
Title: Phase III Randomized Study of Docetaxel and Estramustine vsMitoxantrone and Prednisone in Patients With Advanced Hormone RefractoryProstate Cancer
QOL Instruments/End Points:Pain Medication Log: Patientrecords pain medications

McGill Pain Questionnaire: Tracks changes in pain types andseverity

EORTC QOL Questionnaire—Prostate (PR25): Urination frequencyand urgency; affect on daily activities; hot flashes, sore or enlargednipples/breasts; leg or ankle swelling; weight loss/gain; feeling ofmasculinity; sexual interest; sexual activity; sexual problems

EORTC Core Questionnaire (C30): General physical symptoms,physical functioning, fatigue/malaise, social functioning, psychological stress;specific end points for strenuous or normal physical activities, leisureactivities, short of breath, pain, need for rest, weakness, appetite, nausea,vomiting, constipation, diarrhea, concentration, tense, worry, irritable,depressed, memory, interference with family life or social activities, overallhealth

Protocol Status: Active
Contact: Daniel P. Petrylak, Southwest Oncology Group, (212) 305-1731; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/

Group or Lead Group: SWOG
Protocol Number: SWOG-0003 (active; phase III; adult)
Title: Phase III Randomized Study of Carboplatin and Paclitaxel With orWithout Tirapazamine in Patients With Advanced Non-Small Cell Lung Cancer
QOL Instruments/End Points:Zubrod Performance Scale:Assesses capability of self-care on 0-4 scale from asymptomatic, tosymptomatic, to completely disabled
Protocol Status: Active
Contact: Stephen K. Williamson, Southwest Oncology Group, (913) 588-6029; for a complete listing ofstudy contacts, click hereLatest Information:http://cancernet.nci.nih.gov/