Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer

NCT ID: NCT00005060

Last Updated: 2012-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30
• Study Completion Date: 2006-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Taxotere-Cisplatin-5FU preoperatively

TCF preoperatively

Group Type: ACTIVE_COMPARATOR

Taxotere-Cisplatin-5FU

Intervention Type: DRUG

Preoperatively

Immediate surgery followed by TCF

Surgery followed by Taxotere-Cisplatin-5FU

Group Type: ACTIVE_COMPARATOR

Immediate surgery

Intervention Type: DRUG

Immediate surgery followed by Taxotere-Cisplatin-5FU

Interventions

Taxotere-Cisplatin-5FU

Preoperatively

Intervention Type: DRUG

Immediate surgery

Immediate surgery followed by Taxotere-Cisplatin-5FU

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rudolf Morant, MD

Role: STUDY_CHAIR

Tumor Zentrum ZeTup St. Gallen und Chur

Locations

European Institute of Oncology

Milan, , Italy

Hopital Cantonal Universitaire de Geneve

Geneva, , Switzerland

Zentrum fuer Tumordiagnostikund Praevention

Sankt Gallen, , Switzerland

Countries

Italy; Switzerland

Other Identifiers

SWS-SAKK-43/99

Identifier Type: OTHER

Identifier Source: secondary_id

EU-99042

Identifier Type: -

Identifier Source: secondary_id

SAKK 43/99

Identifier Type: -

Identifier Source: org_study_id