Phase 3
Completed N=855
Trial of Adjuvant Chemotherapy for Gastric Cancer
Stomach Cancer
Source: ClinicalTrials.gov NCT00296335 ↗
Enrolled (actual)
855
Serious AEs
0.9%
Results posted
Feb 2014
Primary outcomePrimary: Relapse-free Survival Rate — 67.0; 64.9 percentage of participants
Summary
This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relapse-free Survival Rate |
67.0; 64.9 | — |
| SECONDARY Overall Survival Rate |
76.9; 73.1 | — |
| SECONDARY Number of Patients With Adverse Events |
262; 387; 393; 413; 101; 156 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00296335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.