- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00009789
Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.
연구 개요
상세 설명
OBJECTIVES:
- Determine the maximum tolerated course of accelerated 3-dimensional conformal radiotherapy in patients with stage I non-small cell lung cancer with pulmonary dysfunction.
- Determine the short-term and long-term toxicity of this regimen in these patients.
- Determine local tumor control, failure-free survival, and overall survival in patients treated with this regimen.
- Determine the effect of radiotherapy dose volume relationships and pre-treatment pulmonary function studies on the incidence of pulmonary toxicity in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.
Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.
Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Florida
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Fort Lauderdale, Florida, 미국, 33308
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
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Hollywood, Florida, 미국, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jupiter, Florida, 미국, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach, Florida, 미국, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, 미국, 60637-1470
- University of Chicago Cancer Research Center
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- Fairview University Medical Center - University Campus
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Missouri
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Chesterfield, Missouri, 미국, 63017
- Saint Luke's Hospital
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Nebraska
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Grand Island, Nebraska, 미국, 68803
- Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
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North Platte, Nebraska, 미국, 69103
- Great Plains Regional Medical Center
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Omaha, Nebraska, 미국, 68198
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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New York
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Buffalo, New York, 미국, 14215
- Veterans Affairs Medical Center - Buffalo
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Oswego, New York, 미국, 13126
- Oswego Hospital
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Syracuse, New York, 미국, 13210
- SUNY Upstate Medical University Hospital
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Syracuse, New York, 미국, 13057
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Syracuse, New York, 미국, 13203
- St. Joseph's Hospital Health Center - Syracuse
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North Carolina
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Charlotte, North Carolina, 미국, 28203
- Blumenthal Cancer Center at Carolinas Medical Center
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Goldsboro, North Carolina, 미국, 27534
- Wayne Memorial Hospital, Incorporated
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Winston-Salem, North Carolina, 미국, 27157
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Columbus, Ohio, 미국, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15224-1791
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC)
- Squamous cell carcinoma
- Basaloid carcinoma
- Adenocarcinoma
- Bronchoalveolar carcinoma
- Adenosquamous carcinoma
- Large cell carcinoma
- Large cell neuroendocrine carcinoma
- Giant cell carcinoma
- Sarcomatoid carcinoma
- Non-small cell carcinoma not otherwise specified
- Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows)
No metastatic disease or hilar or mediastinal lymphadenopathy
Must have mediastinoscopy* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan
- No positive lymph nodes on mediastinoscopy* NOTE: *Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum
Poor surgical risk, as defined by 1 of the following:
- High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy
Pulmonary dysfunction indicated by one or more of the following:
- FEV_1 less than 40% of predicted
- DLCO less than 50% of predicted
- Oxygen dependent
- Chronic PaCO_2 greater than 45 mm Hg
- VO_2 less than 15 mL/kg/min
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- 0-2
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No weight loss of more than 10% within the past 6 months
- No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer
Chemotherapy:
- No prior chemotherapy for NSCLC
Radiotherapy:
- No prior chest radiotherapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Radiotherapy
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks. Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity. Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
전반적인 생존
기간: 최대 5년
|
최대 5년
|
무고장 생존
기간: 최대 5년
|
최대 5년
|
공동 작업자 및 조사자
수사관
- 연구 의자: Jeffrey Bogart, MD, State University of New York - Upstate Medical University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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