Phase 3 N=855 Randomized Treatment

Trial of Adjuvant Chemotherapy for Gastric Cancer

Stomach Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00296335 ↗

Enrolled (actual)

855

Serious AEs

0.9%

Results posted

Feb 2014

Primary outcome: Primary: Relapse-free Survival Rate — 67.0; 64.9 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Mitomycin, doxifluridine and cisplatin (Drug); Mitomycin and doxifluridine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Asan Medical Center
Primary completion: Nov 2007

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	—

Summary

This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.

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

View full record on ClinicalTrials.gov →

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.