A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma


Phase 3
18 Years
75 Years
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Safety Issue:

No

Principal Investigator

Rudolf Morant, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Tumor Zentrum ZeTup St. Gallen und Chur

Authority:

Switzerland: Swissmedic

Study ID:

SAKK 43/99

NCT ID:

NCT00005060

Start Date:

November 1999

Completion Date:

March 2006

Related Keywords:

  • Gastric Cancer
  • stage II gastric cancer
  • stage III gastric cancer
  • Stomach Neoplasms

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