Phase 3
Completed N=521
Trial of Adjuvant Chemotherapy for Gastric Cancer
Stomach Cancer
Source: ClinicalTrials.gov NCT00296322 ↗
Enrolled (actual)
521
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Relapse-free Survival — 50.0; 60.2 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relapse-free Survival |
50.0; 60.2 | — |
| SECONDARY Toxicity Profile (According to NCI CTC Version 2.0) |
13; 30 | — |
| SECONDARY Overall Survival |
59.6; 71.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00296322). 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.