Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer
A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG
연구 개요
상태
개입 / 치료
상세 설명
PRIMARY OBJECTIVES:
I. To determine if adjuvant chemotherapy can favorably alter the prognosis of the subgroup of resected stage I patients who, following complete surgical resection of their disease, are defined as "high risk" based on the presence of a T2N0 tumor (according to the criteria of the International Staging System for lung cancer).
SECONDARY OBJECTIVES:
I To compare failure-free survival of patients with T2N0 stage I NSCLC who have and have not been treated with adjuvant chemotherapy.
II. To determine the toxicities associated with adjuvant chemotherapy. III. To describe the pattern of disease recurrence.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor histology (squamous cell vs nonsquamous cell), degree of differentiation (poorly differentiated vs other), and mediastinal node sampling at surgery (yes vs no). Within 4-8 weeks after surgery, patients are randomized to 1 of 2 treatment arms.
Arm I:Patients receive no further therapy.
Arm II: Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.
Patients are followed every 4 months for 2 years and then every 6 months thereafter.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60606
- Cancer and Leukemia Group B
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically documented non-small cell carcinoma
- Completely resected T2N0M0 Stage I NSCLC as defined by the International Staging System
- Surgery shall consist of a lobectomy or pneumonectomy with resection of associated N1 lymph nodes (either by thoracotomy or thoracoscopy)
- Patients must be randomized within 4 to 8 weeks from the date of complete surgical resection
- No prior chemotherapy or radiation for non-small cell lung cancer
- Performance status of 0 or 1
- Women must be non-pregnant and non-lactating; patients of childbearing potential must agree to use an effective form of contraception while on study
- Patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has bee disease free for five years
- Granulocytes >= 1,800/ul
- Platelets >= 100,000/ul
- Bilirubin < 1.5 mg/dl
- SGOT (AST) < 2.0 x ULN
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Arm I (surgery, observation)
Patients receive no further therapy.
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수술을 받다
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실험적: Arm II (surgery, chemotherapy)
Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1.
Treatment continues every 3 weeks for 4 courses.
|
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
수술을 받다
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall survival (OS)
기간: Up to 2.4 years
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OS curves will be calculated using the Kaplan-Meier life-table method.
Comparison of the survival curve for the two treatment regimens will be performed using the log-rank test for censored data.
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Up to 2.4 years
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Failure-free survival
기간: Time between randomization and disease relapse or death, assessed up to 2.4 years
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Failure-free survival curves will be calculated using the Kaplan-Meier life-table method.
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Time between randomization and disease relapse or death, assessed up to 2.4 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Toxicity as assessed by Common Toxicity Criteria version 2.0
기간: Up to 1 year after completion of treatment
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Up to 1 year after completion of treatment
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Pattern of disease recurrence.
기간: Up to 2 years
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The frequency of local and distant relapse and the incidence of a second primary lung cancer will be tabulated by treatment.
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Up to 2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gary Strauss, Cancer and Leukemia Group B
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 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
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