Clinical trial · Interventional
Trial of Adjuvant Chemotherapy for Gastric Cancer
A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma
NCT00296335CI-TRIAL-00013895completedPhase 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 is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitomycin and doxifluridine | Drug | — | UNRESOLVED |
| Mitomycin, doxifluridine and cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Mitomycin and doxifluridine
- description
- Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
- interventionNames
- Drug: Mitomycin and doxifluridine
- type
- EXPERIMENTAL
- label
- Mitomycin, doxifluridine and cisplatin
- description
- Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
- interventionNames
- Drug: Mitomycin, doxifluridine and cisplatin
Primary outcomes (1)
- measure
- Relapse-free Survival Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven gastric adenocarcinoma * 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: ECOG 0-2 * Adequate bone marrow function (WBC ≥ 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, AST/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 CT * Systemic disease which interfere the administration of chemotherapy * 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.