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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

April 6, 2000
May 14, 2012
November 1999
November 2005   (final data collection date for primary outcome measure)
Event-free survival [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00005060 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • Drug: Taxotere-Cisplatin-5FU
    Preoperatively
  • Drug: Immediate surgery
    Immediate surgery followed by Taxotere-Cisplatin-5FU
  • Active Comparator: Taxotere-Cisplatin-5FU preoperatively
    TCF preoperatively
    Intervention: Drug: Taxotere-Cisplatin-5FU
  • Active Comparator: Immediate surgery followed by TCF
    Surgery followed by Taxotere-Cisplatin-5FU
    Intervention: Drug: Immediate surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
March 2006
November 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Switzerland
 
NCT00005060
SAKK 43/99, SWS-SAKK-43/99, EU-99042
Yes
Swiss Group for Clinical Cancer Research
Swiss Group for Clinical Cancer Research
Not Provided
Study Chair: Rudolf Morant, MD Tumor Zentrum ZeTup St. Gallen und Chur
Swiss Group for Clinical Cancer Research
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP