Health-Related Quality of Life in Cancer Clinical Trials

The Clinical Trials Referral Resource that appeared in the April issue of ONCOLOGY began a series on health-related quality of life (HRQOL). Part I of this series, which concludes this month, focuses on HRQOL questions in cancer treatment trials. Part II (on investigator-initiated HRQOL research) and part III (on HRQOL research as part of cancer prevention trials) will appear in upcoming issues. Information about these studies can be obtained 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.gov or (301) 496-1196.

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, and performance of physical activities, problems and interference with daily activities, 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 of study contacts, click here
Latest 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 Cancer Treated With Intravenous Paclitaxel(Drug information on paclitaxel) and Cisplatin(Drug information on cisplatin) vs IV Paclitaxel, IP Cisplatin and IP Paclitaxel on GOG #172: A Feasibility Study of Assessing Costs and Medical Resource Use
QOL Instruments/End Points: Functional Assessment of Cancer Therapy—Ovarian: Physical, social/family, emotional and functional well-being; additional concerns

• 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 Cancer Center (MDA) and ECOG; Multicenter
Protocol Number: NCI-T97-0069 (active; phase III; adult)
Title: Phase III Randomized Adjuvant Study of Hormonal Therapy in Surgically 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 or in 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 Cancer Center, (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 Recurrent Malignant Glioma
QOL Instruments/End Points: M. D. Anderson Symptom Inventory (MDASI) Core Items: Assesses symptoms in last 24 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, sexual relations, 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, distinguishing outlines in dim lighting, being dazzled by passing from a dim to strongly lit room; 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 of study contacts, click here
Latest 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(Drug information on carmustine) Implant (GLIADEL) in Patients With Recurrent Malignant Glioma
QOL Instruments/End Points: Medical Outcomes Study Short Form 36: Overall health rating; limitations to physical activities; problems at work or in regular daily activity related to physical health or emotional problems; interferences with social activities; pains and interference with normal work; emotional state

• 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: Alessandro Olivi, Johns Hopkins Oncology Center, (410) 550-0465; for a complete listing of study contacts, click here
Latest 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(Drug information on topotecan) and Paclitaxel Preceding and Following High Dose Thoracic Radiotherapy With Concurrent Cisplatin, Etoposide(Drug information on etoposide), and Amifostine(Drug information on 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 of study contacts, click here
Latest 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(Drug information on irinotecan) for Refractory Metastatic Breast Cancer
QOL Instruments/End Points: Functional Assessment of Cancer Therapy—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 of study contacts, click here
Latest 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 With BCNU, Cisplatin, and Oral Etoposide Combined With Radiation Therapy in the Treatment of Grade 3 Astrocytoma (Anaplastic Astrocytoma)
QOL Instruments/End Points: ECOG Performance Score: Physical function

• 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 Linear Analogic Scale: Overall QOL; physical, intellectual, emotional, social, and spiritual 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(Drug information on docetaxel) and Irinotecan in Patients With Advanced Adenocarcinoma of the Lower Esophagus, Esophagogastric Junction, or Gastric 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 of study contacts, click here
Latest 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 Cutaneous Breast Cancer
QOL Instruments/End Points: Functional Assessment of Cancer Therapy—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 of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

Group or Lead Group: NCCTG
Protocol Number: NCCTG-N0022 (approved; phase II; adult [³ 65 years])
Title: Phase II Study of Oral Vinorelbine in Elderly Patients With Stage IIIB 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 of study contacts, click here
Latest 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 Glioblastoma Multiforme
QOL Instruments/End Points: Linear Analog Scale: Physical, emotional, spiritual, intellectual, and overall well-being

• Epworth Sleepiness Scale: Chance of dozing while sitting and reading, watching TV, sitting inactive in a public place, as a passenger in a car for an hour without a break, lying down to rest in the afternoon, sitting and talking to someone, sitting quietly after lunch without alcohol(Drug information on alcohol), in a car while stopped a few minutes in traffic

• Profile of Mood Status: Assesses mood states: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-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 additional concerns (concentration, seizures, memory, frustration, fear of seizure, vision, independence, hearing, finding right words, expression of thoughts, change of personality, ability to make decisions and take responsibility, contribution to toxicity, putting thoughts together, help in self care, put thoughts into action, reading, writing, driving)

Protocol Status: Active
Contact: Joon H. Uhm, North Central Cancer Treatment Group, (507) 284-3559; for a complete listing of study contacts, click here
Latest 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 of Laparoscopic-Assisted Colectomy vs Open Colectomy for Colon Cancer
QOL Instruments/End Points: Symptom Distress Scale: Nausea frequency, 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 of study contacts, click here
Latest 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(Drug information on letrozole) Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen(Drug information on tamoxifen)
QOL Instruments/End Points: SF-36 Health Status Survey: Overall health status, physical limitations, and problems with work or other daily activities, social activity; pain and interference with normal work; emotional feelings

• 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(Drug information on oxaliplatin), Fluorouracil(Drug information on fluorouracil), and Leucovorin Calcium in Patients With Advanced Colorectal Cancer Previously 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 of study contacts, click here
Latest 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 in Patients 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; additional concerns

• 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 of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

* Cancer Trials Support Unit (CTSU) investigators with scientific questions about this trial should contact the principal investigator at the sponsoring Cooperative Group. CTSU investigators interested in enrolling patients on this trial through the CTSU should contact the 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 Patients With Advanced Adenocarcinoma of the Colon and Rectum
QOL Instruments/End Points: Symptom Distress Scale: Overall level of 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 of study contacts, click here
Latest 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 Chemotherapy With Vinorelbine and Cisplatin in Completely Resected Non-Small-Cell Lung Cancer With Companion Tumor Marker Evaluation
QOL Instruments/End Points: EORTC Core Questionnaire (QLQ-C30 + 3): General physical symptoms, physical functioning, fatigue/malaise, social functioning, psychological stress (specific end points similar to QLQ-C30 instrument: see #42 below)
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 Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer
QOL Instruments/End Points: EORTC Core Questionnaire (QLQ-C30): General physical symptoms, physical functioning, fatigue/malaise, social functioning, psychological stress; specific end points for strenuous or normal physical activities, 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 social activities, 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: see footnote)*

Group or Lead Group: NCIC; Intergroup
Protocol Number: T94-0110 (active; phase III; adult)
Title: Randomized Trial Comparing Total Androgen Blockade vs Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3-4, N0, M0 Adenocarcinoma of the Prostate
QOL Instruments/End Points: EORTC Core Questionnaire 33: Strenuous to 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, overall physical condition/health/QOL, emotional state, social enjoyment, bladder control, 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 Breast and Bowel Project (NSABP)
Protocol Number: NSABP-B-30 (active; phase III; adult)
Title: Phase III Randomized Study of Adjuvant Doxorubicin and Cyclophosphamide(Drug information on cyclophosphamide) Followed by Docetaxel Versus Doxorubicin(Drug information on doxorubicin) and Docetaxel Versus Doxorubicin, Docetaxel, and Cyclophosphamide in Women With Breast Cancer and Positive 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 Bowel Project, (301) 496-4916 (CTSU Investigators: see footnote)*; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

* Cancer Trials Support Unit (CTSU) investigators with scientific questions about this trial should contact the principal investigator at the sponsoring Cooperative Group. CTSU investigators interested in enrolling patients on this trial through the CTSU should contact the 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-Idiotype Vaccine and Monoclonal Antibody 3H1 Anti-Idiotype Vaccine With Radiotherapy in Patients With Completely Resected Stage II or IIIA Non-Small Cell Lung Cancer
QOL Instruments/End Points: Patient Swallowing Diary: (No further information available)
Protocol Status: Active
Contact: Benjamin Movsas, Radiation Therapy Oncology Group, (215) 728-5304; for a complete listing of study contacts, click here
Latest 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 Conformal Stereotactic Radiotherapy Boost Followed by Carmustine in Patients With Supratentorial Glioblastoma Multiforme
QOL Instruments/End Points: Neurologic Function Status: Neurologic symptoms on scale from none to severe based on activity at home/work and amount of 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 of study contacts, click here
Latest 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 Concurrent Radiotherapy With or Without Fluorouracil in Patients With Previously Untreated Carcinoma of the Esophagus or Gastroesophageal Junction
QOL Instruments/End Points: Functional Assessment of Cancer Therapy—Head and Neck (version 2): Physical and functional well-being scale, additional concerns for head and neck cancer therapy (difficulties in subjective assessment due 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 of study contacts, click here
Latest 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 Without Intensive Procarbazine(Drug information on procarbazine), Lomustine(Drug information on lomustine), and Vincristine (PCV) in Patients With Unifocal or Multifocal, Supratentorial, Pure or Mixed Anaplastic Oligodendroglioma
QOL Instruments/End Points: Karnofsky Performance Scale: Global functioning in terms of degree of mobility, ability to maintain employment, live at 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 of study contacts, click here
Latest 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 Without Neoadjuvant Flutamide(Drug information on flutamide) Plus Goserelin or Leuprolide in Patients With Good Prognosis, Locally Confined Adenocarcinoma of the Prostate
QOL Instruments/End Points: Sexual Adjustment Questionnaire (use of questionnaire 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 of study contacts, click here
Latest 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 in Patients with Favorable Performance Inoperable Stage II, IIIA, or IIIB Non-Small Cell Lung Cancer Receiving Sequential Induction and Concurrent Hyperfractioned Radiotherapy with Paclitaxel and Carboplatin(Drug information on carboplatin)
QOL Instruments/End Points: EORTC Core Questionnaire (C30): General physical symptoms, physical functioning, fatigue/malaise, social functioning, 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 of study contacts, click here
Latest 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 Epoetin Alfa 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 of study contacts, click here
Latest 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 in Patients With Brain Metastases
QOL Instruments/End Points: Profile of Mood States—Short Form: Assesses mood 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 of study contacts, click here
Latest 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 in Advanced or Metastatic Chemonaive Non-Small-Cell Lung Cancer (NSCLC)
QOL Instruments/End Points: Zubrod Performance Scale: Assesses capability of self-care on 0-4 scale from asymptomatic to symptomatic to completely 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 Transitional Cell Carcinoma of the Urothelium
QOL Instruments: Zubrod Performance Scale: Assesses capability of self-care on 0-4 scale from asymptomatic, to symptomatic, to completely disabled
Protocol Status: Active
Contact: Daniel P. Petrylak, Southwest Oncology Group, (212) 305-1731 (CTSU Investigators: see footnote)*; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/

* Cancer Trials Support Unit (CTSU) investigators with scientific questions about this trial should contact the principal investigator at the sponsoring Cooperative Group. CTSU investigators interested in enrolling patients on this trial through the CTSU should contact the 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 Constant Combined Androgen Deprivation (Bicalutamide and Goserelin) in Patients With Stage IV Prostate Cancer Responsive to Such Therapy
QOL InstrumentsEnd Points: SWOG Performance Status: Physical activity

• 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, breast tenderness, crampy/abdominal pain, proctitis, urine flow, incontinence, hot flashes, and ability to have erection

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

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

Protocol Status: Active
Contact: Maha Hadi A. Hussain, Southwest Oncology Group, (313) 745-2357; for a complete listing of study contacts, click here
Latest 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(Drug information on estramustine) vs Mitoxantrone(Drug information on mitoxantrone) and Prednisone(Drug information on prednisone) in Patients With Advanced Hormone Refractory Prostate Cancer
QOL Instruments/End Points: Pain Medication Log: Patient records pain medications

• McGill Pain Questionnaire: Tracks changes in pain types and severity

• EORTC QOL Questionnaire—Prostate (PR25): Urination frequency and urgency; affect on daily activities; hot flashes, sore or enlarged nipples/breasts; leg or ankle swelling; weight loss/gain; feeling of masculinity; 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, 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 social activities, overall health

Protocol Status: Active
Contact: Daniel P. Petrylak, Southwest Oncology Group, (212) 305-1731; for a complete listing of study contacts, click here
Latest 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 or Without 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, to symptomatic, to completely disabled
Protocol Status: Active
Contact: Stephen K. Williamson, Southwest Oncology Group, (913) 588-6029; for a complete listing of study contacts, click here
Latest Information: http://cancernet.nci.nih.gov/