Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immediate surgery | Drug | — | UNRESOLVED |
| Taxotere-Cisplatin-5FU | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Taxotere-Cisplatin-5FU preoperatively
- description
- TCF preoperatively
- interventionNames
- Drug: Taxotere-Cisplatin-5FU
- type
- ACTIVE_COMPARATOR
- label
- Immediate surgery followed by TCF
- description
- Surgery followed by Taxotere-Cisplatin-5FU
- interventionNames
- Drug: Immediate surgery
Primary outcomes (1)
- measure
- Event-free survival
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available