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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00005060
First received: April 6, 2000
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: Taxotere-Cisplatin-5FU
Drug: Immediate surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Time to treatment failure measured after completion of study treatment [ Designated as safety issue: No ]
  • Toxicity measured after completion of study treatment [ Designated as safety issue: Yes ]
  • Rate of complete resection (RO) and postoperative mortality as measured after surgery [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: November 1999
Study Completion Date: March 2006
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Taxotere-Cisplatin-5FU preoperatively
TCF preoperatively
Drug: Taxotere-Cisplatin-5FU
Preoperatively
Active Comparator: Immediate surgery followed by TCF
Surgery followed by Taxotere-Cisplatin-5FU
Drug: Immediate surgery
Immediate surgery followed by Taxotere-Cisplatin-5FU

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005060

Locations
Italy
European Institute of Oncology
Milan, Italy, 20141
Switzerland
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Zentrum fuer Tumordiagnostikund Praevention
St. Gallen, Switzerland, CH-9006
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Rudolf Morant, MD Tumor Zentrum ZeTup St. Gallen und Chur
  More Information

No publications provided

Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00005060     History of Changes
Other Study ID Numbers: SAKK 43/99, SWS-SAKK-43/99, EU-99042
Study First Received: April 6, 2000
Last Updated: May 14, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Group for Clinical Cancer Research:
stage II gastric cancer
stage III gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 16, 2014