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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Taxotere-Cisplatin-5FU
Immediate surgery
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring stage II gastric cancer, stage III gastric cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • European Institute of Oncology
  • Hopital Cantonal Universitaire de Geneve
  • Zentrum fuer Tumordiagnostikund Praevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Taxotere-Cisplatin-5FU preoperatively

Immediate surgery followed by TCF

Arm Description

TCF preoperatively

Surgery followed by Taxotere-Cisplatin-5FU

Outcomes

Primary Outcome Measures

Event-free survival

Secondary Outcome Measures

Overall survival
Time to treatment failure measured after completion of study treatment
Toxicity measured after completion of study treatment
Rate of complete resection (RO) and postoperative mortality as measured after surgery

Full Information

First Posted
April 6, 2000
Last Updated
May 14, 2012
Sponsor
Swiss Group for Clinical Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00005060
Brief Title
Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer
Official Title
A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
stage II gastric cancer, stage III gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taxotere-Cisplatin-5FU preoperatively
Arm Type
Active Comparator
Arm Description
TCF preoperatively
Arm Title
Immediate surgery followed by TCF
Arm Type
Active Comparator
Arm Description
Surgery followed by Taxotere-Cisplatin-5FU
Intervention Type
Drug
Intervention Name(s)
Taxotere-Cisplatin-5FU
Intervention Description
Preoperatively
Intervention Type
Drug
Intervention Name(s)
Immediate surgery
Intervention Description
Immediate surgery followed by Taxotere-Cisplatin-5FU
Primary Outcome Measure Information:
Title
Event-free survival
Secondary Outcome Measure Information:
Title
Overall survival
Title
Time to treatment failure measured after completion of study treatment
Title
Toxicity measured after completion of study treatment
Title
Rate of complete resection (RO) and postoperative mortality as measured after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf Morant, MD
Organizational Affiliation
Tumor Zentrum ZeTup St. Gallen und Chur
Official's Role
Study Chair
Facility Information:
Facility Name
European Institute of Oncology
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Hopital Cantonal Universitaire de Geneve
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland
Facility Name
Zentrum fuer Tumordiagnostikund Praevention
City
St. Gallen
ZIP/Postal Code
CH-9006
Country
Switzerland

12. IPD Sharing Statement

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

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