XELOX for 4 Months Versus 6 Months in Gastric Cancer (LOMAC)

Gastric Cancer Clinical Trial

Official title: XELOX for 4 Months Versus 6 Months as Adjuvant Chemotherapy in Gastric Cancer After D2 Resection (LOMAC)

Status Active, not recruiting

Clinical Trial Summary

Our study aims to compare the efficacy and safety of capecitabine and oxaliplatin for 4 months versus 6 months as adjuvant chemotherapy after D2 Gastrectomy in patients with gastric cancer.

Hypothesis: For gastric patients after D2 Gastrectomy, capecitabine and oxaliplatin for 4 months show noninferiority to capecitabine and oxaliplatin for 6 months in disease-free survival (DFS) and safety.

Clinical Trial Description

Surgical resection is the cornerstone of treatment for patients with localized gastric cancer. Capecitabine plus oxaliplatin for 6 months after D2 gastrectomy is considered as effective postoperative adjuvant treatment for patients with operable stage II or III gastric cancer in the CLASSIC trail. However, because of adverse events discontinuations in the chemotherapy group occurred in 50 (10%) patients, mainly as a result of nausea, neutropenia, decreased appetite, peripheral neuropathy, diarrhea, and vomiting. At the 2017 ASCO Annual Meeting, Grothey et al reported the result of IDEA trail. For lymph node-positive colon cancer (stage III), some patients may need only half of the long-standing standard course of chemotherapy after surgery. In an analysis of 6 clinical trials with over 12,800 patients, 3 months of chemotherapy was nearly as effective as 6 months in patients with relatively lower recurrence risk and caused fewer side effects, particularly nerve damage. Based on IDEA trail, we postulate that the chemotherapy of capecitabine plus oxaliplatin for 4 months may also benefit patients after D2 gastrectomy and decrease adverse events compared with 6 months. ;

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

• NCT number: NCT03399110
• Study type: Interventional
• Source: Fudan University
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 1, 2017
• Completion date: August 1, 2026