Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer
A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery may kill more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective than surgery followed by chemotherapy for stomach cancer.
PURPOSE: This randomized phase III trial is studying surgery followed by combination chemotherapy to see how well it works compared to combination chemotherapy followed by surgery in treating patients with locally advanced stomach cancer.
연구 개요
상세 설명
OBJECTIVES:
- Compare, by intention to treat analysis, feasibility and efficacy of 4 courses of docetaxel, cisplatin, and fluorouracil as preoperative or postoperative chemotherapy in patients with locally advanced operable gastric carcinoma.
- Evaluate the predictive values of some biological and molecular tumor parameters on response to chemotherapy, metastasis and survival in this patient population.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to study center, tumor site (affecting the Z-line (cardia carcinoma Siewart II and III) vs rest of the stomach), and nodal status (positive vs negative). Patients are randomized to either preoperative chemotherapy followed by surgery (arm I) or surgery followed by postoperative chemotherapy (arm II).
- Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 4 hours on day 1, and fluorouracil IV continuously on days 1-14 every 3 weeks. Patients are evaluated after 2 courses and patients with progressive disease proceed to immediate surgery. Otherwise, treatment continues for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Between 3-5 weeks following day 1 of the last course of chemotherapy, patients undergo gastric resection.
- Arm II: Patients undergo immediate gastric resection. Beginning 3-6 weeks after surgery, patients receive 4 courses of docetaxel, cisplatin, and fluorouracil as in arm I.
Quality of life is assessed before the first and third courses of chemotherapy, before and after surgery, and then at 1, 3, and 6 months.
Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 240 patients (120 per arm) will be accrued for this study.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed locally advanced gastric carcinoma that is considered operable
- T3-4, Nx, M0 OR
- Tx, N+, M0
Lymph nodes considered positive by sonography should be at least 2 of the following:
- Round
- Echopoor
- Sharp borders
- At least 0.5 cm
No distant metastases, including peritoneal carcinomatosis
- CT scan and peritoneal lavage mandatory
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- 0-2
Life expectancy:
- Greater than 12 weeks
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin normal
- AST or ALT no greater than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Adequate renal function within limits to allow for treatment with cisplatin
Cardiovascular:
- No unstable cardiac disease requiring treatment
- No congestive heart failure or angina pectoris even if medically controlled
- No significant arrhythmias
- No myocardial infarction within past 6 months
- Ejection fraction greater than 50% on cardiac sonography or MUGA scan
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy except basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix
- No grade 2 or greater peripheral neuropathy of any origin (e.g., alcohol, diabetic)
- No history of anaphylaxis
- No other serious concurrent illness or medical condition that would preclude study therapy
- No history of significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic therapy for gastric carcinoma
Chemotherapy:
- No other concurrent chemotherapy for gastric carcinoma
Endocrine therapy:
- No concurrent endocrine therapy for gastric carcinoma
Radiotherapy:
- No concurrent radiotherapy for gastric carcinoma
Surgery:
- See Disease Characteristics
Other:
- At least 30 days since prior treatment in a clinical trial
- No other concurrent experimental drugs
- No other concurrent anticancer therapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Taxotere-Cisplatin-5FU preoperatively
TCF preoperatively
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Preoperatively
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활성 비교기: Immediate surgery followed by TCF
Surgery followed by Taxotere-Cisplatin-5FU
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Immediate surgery followed by Taxotere-Cisplatin-5FU
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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사건 없는 생존
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2차 결과 측정
결과 측정 |
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전반적인 생존
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연구 치료 완료 후 측정된 치료 실패까지의 시간
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Toxicity measured after completion of study treatment
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Rate of complete resection (RO) and postoperative mortality as measured after surgery
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공동 작업자 및 조사자
수사관
- 연구 의자: Rudolf Morant, MD, Tumor Zentrum ZeTup St. Gallen und Chur
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
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