NCT00591045

Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer

A Randomized Phase II Multicenter Controlled Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 263 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized phase II multicenter controlled study of oxaliplatin, calcium folinate, and 5-fluorouracil (mFOLFOX7) as neoadjuvant chemotherapy for resectable advanced gastric cancer. Hypothesis: Neoadjuvant chemotherapy may improve 5 year overall survival compared with the control.

Detailed description

The study hypothesis is that the 5 year survival rate will reach 35% from 25% when neoadjuvant chemotherapy is carried out. With the alpha value to be 0.05 and beta value to be 0.80 as well as 10 percent of patients' lost-of-followup, the sample size will be 263.

Conditions

• Stomach Neoplasms
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	mFOLFOX	oxaliplatin 100mg/m2, CF 400mg/m2, 5-FU 2400 mg/m2 46hr civ

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-01-11
• Last updated: 2008-01-11

Locations

1 site across 1 country: China