Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Swiss Group for Clinical Cancer Research |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004873 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating advanced stomach cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of combination chemotherapy in treating patients who have advanced stomach cancer.
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer |
Drug: cisplatin Drug: docetaxel Drug: epirubicin hydrochloride Drug: fluorouracil |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Taxotere-Cisplatin-5FU (TCF) Versus Taxotere-Cisplatin (TC) Versus Epirubicin-Cisplatin-5FU (ECF) as Systemic Treatment for Advanced Gastric Carcinoma: A Randomized Phase II Trial |
Study Start Date: | August 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, performance status (0 vs 1), and liver involvement (yes vs no). Patients are randomized to one of three treatment arms.
Treatment regimen is repeated every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed before randomization; at day 1 of courses 2, 4, and 6; and one month after treatment failure.
Patients with complete response or partial response are followed monthly for 3 months.
PROJECTED ACCRUAL: Approximately 111 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed gastric carcinoma not amenable to curative surgery or in relapse after primary surgical resection
Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Switzerland | |
Hopital Cantonal Universitaire de Geneva | |
Geneva, Switzerland, CH-1211 |
Study Chair: | Arnaud Roth, MD | Hopital Cantonal Universitaire de Geneve |
Study ID Numbers: | CDR0000067533, SWS-SAKK-42/99, EU-99021 |
Study First Received: | March 7, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004873 |
Health Authority: | United States: Federal Government |
stage III gastric cancer stage IV gastric cancer recurrent gastric cancer |
Digestive System Neoplasms Gastrointestinal Diseases Stomach cancer Epirubicin Recurrence Carcinoma Docetaxel |
Digestive System Diseases Stomach Diseases Cisplatin Stomach Neoplasms Fluorouracil Gastrointestinal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |