Clinical trial · Interventional
Trial of Adjuvant Chemotherapy for Gastric Cancer
A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Gastric Adenocarcinoma: Mitomycin and Doxifluridine Versus Intraperitoneal Chemotherapy and Mitomycin, Doxifluridine, and Cisplatin
NCT00296322CI-TRIAL-00042837completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine in resected advanced gastric 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 |
|---|---|---|---|
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin, mitomycin-C, doxifluridine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Mitomycin-C, Doxifluridine
- description
- Mf: Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
- interventionNames
- Drug: cisplatin, mitomycin-C, doxifluridine
- type
- ACTIVE_COMPARATOR
- label
- Mitomycin-C, Doxifluridine, Cisplatin
- description
- iceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxifluridine 460-600mg/m2/day per oral(started at 4 weeks after surgery and administered a total of 12 months) Cisplatin 60mg/m2 intravenously monthly for 6 months (started at 4 weeks after surgery)
- interventionNames
- Drug: cisplatin, mitomycin-C, doxifluridine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven gastric adenocarcinoma * Grossly serosa invasion of primary tumor is suspicious * Curative resection was done * Stage II, IIIA, IIIB, IV (including T4, lesions or N3, but excluding M1 lymph node metastasis) * Age: 18-69 years old * Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 * Adequate bone marrow function (white blood cell counts ≥ 4,000/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 10 g/dl) * Adequate renal function (serum creatinine≤ 1.5) * Adequate liver function (serum bilirubin ≤1.5 mg/dl, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x normal upper limit) * Written informed consent was signed by the patient Exclusion Criteria: * Previous chemotherapy or radiotherapy * Active ongoing infection which antibiotic treatment is needed * Pregnant or lactating women * Psychosis or convulsion disorder * Ascites in preoperative abdomen computed tomography (CT) * Systemic disease which interfere the administration of chemotherapy * Postoperative pathologic stage IA, IB * Postoperative pathology indicates that resection margin is involved * Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ
References
Publications (0)
Data not yet available
No reference posted for this study.