Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Phase I Study of Accelerated Hypofractionated Radiation Therapy With Concomitant Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer
연구 개요
상세 설명
PRIMARY OBJECTIVES:
I. To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated hypofractionated radiotherapy with concurrent chemotherapy.
SECONDARY OBJECTIVES:
I. To evaluate the rate of radiographic response to treatment. II. To estimate the rates of progression: local/regional/distant. III. To estimate the progression-free survival. IV. To estimate the overall survival.
OUTLINE: This is a dose-escalation study of accelerated hypofractionated radiotherapy.
CONCURRENT THERAPY: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1 and 8. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo accelerated hypofractionated radiotherapy using 3-dimensional conformal radiation therapy or intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for approximately 4-5.5 weeks.
CONSOLIDATION THERAPY: Beginning 4 weeks after completion of radiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month, 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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Arizona
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Phoenix, Arizona, 미국, 85054
- Mayo Clinic Hospital
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Scottsdale, Arizona, 미국, 85259
- Mayo Clinic Scottsdale
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California
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La Jolla, California, 미국, 92093-0987
- Moores University of California San Diego Cancer Center
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Illinois
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Chicago, Illinois, 미국, 60637
- University of Chicago
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Maryland
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Baltimore, Maryland, 미국, 21201
- University of Maryland/Greenebaum Cancer Center
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Dana Farber Cancer Institute
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New York
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Syracuse, New York, 미국, 13210
- State University of New York Upstate Medical University
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599-7305
- University of North Carolina - Chapel Hill
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Winston-Salem, North Carolina, 미국, 27157-1030
- Wake Forest University Health Sciences
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital
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Vermont
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Burlington, Vermont, 미국, 05401
- University of Vermont
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
- Histologically or cytologically documented non-small cell lung cancer
- Stage IIIA or IIIB non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) version 7; patients who present with N2 or N3 disease and an undetectable primary tumor are also eligible
- Thoracic disease without supraclavicular or contralateral hilar involvement
- When pleural fluid is visible on both computed tomography (CT) scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; exudative pleural effusions are excluded regardless of cytology; patients with effusions that are minimal (i.e., not visible on chest x-ray) and too small to safely tap are eligible
- No prior radiotherapy or chemotherapy for NSCLC
- No prior mediastinal or thoracic radiotherapy
- Patients with complete surgical resection of disease are not eligible, however; patients with surgical resection and measurable gross residual disease present on imaging are considered eligible
Patients must have measurable disease
- Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral CT scan
Patients with non-measurable disease are not eligible; all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions; lesions that are considered non-measurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- No patients that are known to be pregnant or nursing
- Granulocytes ≥ 1,500/μl Platelet count ≥ 100,000/μl Bilirubin ≤ 1.5 times upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxalo-acetic transaminase [SGOT]) ≤ 2.0 times ULN Serum creatinine ≤ 1.5 times ULN OR calculated creatinine clearance >= 70 mL/min FEV-1 ≥ 1.2 L/sec or 50% predicted
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: Concurrent therapy + consolidation therapy
Concurrent Therapy (1 cycle = 14 days, Cycles 1-3): Patients will receive paclitaxel 45 mg/m^2 by IV over 1 hour weekly followed by carboplatin AUC 2 by IV over 30-60 minutes for 4 weeks (there will be no chemotherapy during Cycle 3). Patients will receive radiotherapy concurrently for up to 5.5 weeks, depending on the cohorts the patient is registered defined per the protocol. Consolidation Therapy (1 cycle = 21 days, Cycles 4-5): Four weeks following the end of radiotherapy patients will receive paclitaxel 200 mg/m^2 by IV over 3 hours followed by carboplatin AUC 6 by IV over 30-60 minutes on day 1 of each 21 day cycle for a total of 2 cycles (days 1 and 22). |
IV
IV
Defined per the protocol
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Maximum-tolerated RT dose fraction
기간: Up to 28 months
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Up to 28 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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무진행 생존
기간: 최대 5년
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최대 5년
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전반적인 생존
기간: 최대 5년
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최대 5년
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Radiographic response
기간: Up to 5 years
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Up to 5 years
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Metabolic response
기간: Up to 5 years
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Up to 5 years
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Rates of progression: local/regional/distant
기간: Up to 5 years
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Up to 5 years
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공동 작업자 및 조사자
수사관
- 연구 의자: James J. Urbanic, MD, Wake Forest University Health Sciences
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
- CALGB 31102
- U10CA180821 (미국 NIH 보조금/계약)
- U10CA031946 (미국 NIH 보조금/계약)
- CDR0000719011 (레지스트리 식별자: Physician Data Query)
- NCI-2012-00087 (레지스트리 식별자: NCI Clinical Trial Reporting Program)
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