- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00003685
Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
A Phase III Trial of Single Versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patients With Non-Small Cell Lung Cancer
RATIONALE: Radiation therapy may relieve symptoms in patients with non-small cell lung cancer. It is not yet known which regimen of radiation therapy is most effective in relieving symptoms in patients with non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy to relieve symptoms in patients who have non-small cell lung cancer.
연구 개요
상태
상세 설명
OBJECTIVES: I. Compare the efficacy of two schedules of radiotherapy in the palliation of symptoms in patients with non-small cell lung cancer. II. Compare the toxicity of these two regimens in these patients. III. Compare the quality of life and survival of patients treated with these two regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, weight loss in the previous 6 months (no greater than 10% vs greater than 10%), and performance status (ECOG 0 or 1 vs 2 or 3). Patients are randomized to undergo radiotherapy as 5 fractions over 5 days or 1 fraction on 1 day. Quality of life is assessed before treatment, weekly for 5 weeks, and monthly thereafter. Patients are followed weekly for 5 weeks, then every 2 months for 1 year.
PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Alberta
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Calgary, Alberta, 캐나다, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Edmonton, Alberta, 캐나다, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Surrey, British Columbia, 캐나다, V3V 1Z2
- British Columbia Cancer Agency - Fraser Valley Cancer Centre
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Vancouver, British Columbia, 캐나다, V5Z 4E6
- BC Cancer Agency
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Victoria, British Columbia, 캐나다, V8R 1J8
- British Columbia Cancer Agency - Vancouver Island Cancer Centre
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Manitoba
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Winnipeg, Manitoba, 캐나다, R3E 0V9
- CancerCare Manitoba
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New Brunswick
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Moncton, New Brunswick, 캐나다, E1C 8X3
- Doctor Leon Richard Oncology Centre
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Saint John, New Brunswick, 캐나다, E2L 4L2
- Saint John Regional Hospital
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, 캐나다, A1B 3V6
- Dr. H. Bliss Murphy Cancer Centre
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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Hamilton, Ontario, 캐나다, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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Kingston, Ontario, 캐나다, K7L 5P9
- Kingston Regional Cancer Centre
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Ottawa, Ontario, 캐나다, K1Y 4K7
- Ottawa Regional Cancer Centre - Civic Campus
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Ottawa, Ontario, 캐나다, K1H 8L6
- Ottawa Regional Cancer Center - General Division
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Peterborough, Ontario, 캐나다, K9H 7B6
- Peterborough Oncology Clinic
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St. Catharines, Ontario, 캐나다, L2R 5K3
- Hotel Dieu Hospital - St. Catharines
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Sudbury, Ontario, 캐나다, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
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Thunder Bay, Ontario, 캐나다, P7A 7T1
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
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Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret Hospital
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Windsor, Ontario, 캐나다, N8W 2X3
- Cancer Care Ontario - Windsor Regional Cancer Centre
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Saskatchewan
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Saskatoon, Saskatchewan, 캐나다, S7N 4H4
- Saskatoon Cancer Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS: Histologically or cytologically proven non-small cell lung cancer Squamous cell lung cancer Large cell lung cancer Adenocarcinoma lung cancer Mixture of above Locally advanced disease for which the patient declined aggressive treatment or that is unsuitable for aggressive curative treatment due to at least one of the following: Performance status of ECOG 2 or 3 Otherwise unexplained weight loss greater than 10% in the last 6 months Bulky disease that cannot be irradiated safely to high doses Inability to tolerate chemotherapy Cytologically positive pleural effusion OR Clinically or radiologically proven metastatic disease for which palliative chemotherapy is not planned in the first 38 days after radiotherapy No more than one brain metastasis allowed One of the following symptoms identified as the index symptom: Loss of appetite Nausea Vomiting Cough Coughing up blood Chest pain Shortness of breath Difficulty swallowing Fatigue Must have symptoms related to intrathoracic lung cancer that are amenable to radiation palliation
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-3 Life expectancy: Greater than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Fluent in English or French No loss of sight or other inability to complete questionnaires or diary Not pregnant No concurrent terminal illness No other active malignancy that is causing symptoms or is expected to progress in the next 3 months
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 30 days since prior chemotherapy and failed No planned chemotherapy within 38 days after study treatment Endocrine therapy: Not specified Radiotherapy: No planned laser therapy within 38 days after study treatment Surgery: At least 30 days since prior surgery and failed Other: No planned photodynamic therapy or sclerotherapy within 38 days after study treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
공동 작업자 및 조사자
수사관
- 연구 의자: Andrea Bezjak, MD, MSC, FRCPC, Princess Margaret Hospital, Canada
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SC15
- CAN-NCIC-SC15 (기타 식별자: PDQ)
- CDR0000066787 (기타 식별자: PDQ)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
삶의 질에 대한 임상 시험
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University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH)완전한
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Queens College, The City University of New York모병
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Swansea University완전한A Bite of ACT' (BOA) 수용전념치료 온라인 심리교육 과정 | 대기자 명단 제어영국
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Hôpital Léon Bérard완전한
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Yale-NUS College완전한연구 초점은 SGH Life Center에서 관리하는 비만 관리 설문지에 대한 환자의 반응입니다.싱가포르
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Scripps Translational Science Institute완전한
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Novartis Pharmaceuticals완전한신경내분비종양 | GI 오리진의 고급 NET | 고급 NET of Lung Origin미국, 콜롬비아, 이탈리아, 대만, 영국, 벨기에, 체코, 독일, 일본, 사우디 아라비아, 캐나다, 네덜란드, 스페인, 대한민국, 레바논, 오스트리아, 중국, 그리스, 남아프리카, 태국, 헝가리, 칠면조, 폴란드, 슬로바키아, 러시아 연방
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Yale-NUS College완전한
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University Hospital Inselspital, BerneDeka Medical, Inc.모집하지 않고 적극적으로
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University of Pennsylvania완전한Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410의 주진단 또는 이차진단 코드가 있는 환자(5번째 숫자가 2인 경우 제외)미국
방사선 요법에 대한 임상 시험
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Alpha Tau Medical LTD.European Organisation for Research and Treatment of Cancer - EORTC아직 모집하지 않음
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Alpha Tau Medical LTD.모병
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Alpha Tau Medical LTD.모병
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Alpha Tau Medical LTD.모집하지 않고 적극적으로