Randomized Phase III Study of Preoperative Chemotherapy Followed by Surgery Versus Surgery Alone in Locally Advanced Gastric Cancer (cT3 and cT4NxM0)
cisplatin
+ fluorouracil
+ leucovorin calcium
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
Treatment Study
Summary
Study start date: July 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: Compare overall survival in patients with locally advanced gastric cancer treated with surgery alone or in combination with neoadjuvant cisplatin, leucovorin calcium and fluorouracil. Compare these two regimens in terms of the rate of complete resection, time to progression, and morbidity in these patients. Evaluate toxicity of and disease response to neoadjuvant chemotherapy in these patients. Evaluate quality of life and performance status in these patients pre- and post-surgery and compare quality of life for both regimens. OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to center, primary tumor category (cT3 or cT4), localization of tumor (upper third including cardia II or III vs middle and lower third), gender, and histological subtype (intestinal vs nonintestinal). Patients are randomized to one of two treatment arms. Arm I: Patients receive cisplatin IV over 1 hour on days 1, 15, and 29. Patients also receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on days 1, 8, 15, 22, 29, and 36. A second course is administered beginning 2 weeks later in the absence of disease progression or unacceptable toxicity. Patients undergo resection and lymphadenectomy on days 57-63 of the second course of chemotherapy. Arm II: Patients undergo resection and lymphadenectomy within 14 days of randomization. Quality of life is assessed before randomization, every 3 months for 1 year and at 2 years after randomization. Patients are followed every 3 months for 1 year, every 6 months for 2 years, then every 3 months thereafter until death. PROJECTED ACCRUAL: A total of 360 patients (180 per arm) will be accrued for this study over 4 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.144 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 69 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically proven stage II-IV adenocarcinoma of the stomach including cardia carcinoma types II and III Locally resectable disease No distant metastases except M1 lymph nodes No evidence of peritoneal carcinomatosis Free tumor cells in lavage at laparoscopy allowed No uncontrolled bleeding of the primary tumor No gastric outlet syndrome or complete tumor stenosis that would require total parenteral nutrition PATIENT CHARACTERISTICS: Age: 18 to 69 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm^3 Absolute neutrophil count greater than 2,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) Prothrombin rate at least 70% Renal: Creatinine no greater than 1.25 times ULN Creatinine clearance greater than 60 mL/min Cardiovascular: No prior atrial or ventricular arrhythmias No prior congestive heart failure No myocardial infarction within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior or concurrent neoplasm except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No active infection No allergy to protocol drugs No dementia or significantly altered mental status No other serious medical condition that would prevent compliance PRIOR CONCURRENT THERAPY: Biologic therapy: No filgrastim (G-CSF) within 48 hours prior to chemotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No prior stent implantation No prior laser therapy
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 18 locations
National Cancer Institute of Egypt
Cairo, EgyptRobert Roessle Klinik
Berlin, GermanyKlinik & Poliklinik fur Strahlentherapie der Universitat zu Koln
Cologne, Germany