The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer

• Status: Recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open-label study done in 3 hospitals in China. Patients with stage IIIB and IIIC gastric cancer who undergo curative D2 gastrostomy will be randomly assigned after surgery to receive adjuvant chemotherapy with oxaliplatin and capecitabine, or adjuvant chemotherapy combined Traditional Chinese treatment. The primary outcome was disease-free survival and 3-year disease-free survival rate in the intention-to-treat population.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Jiangsu Province Hospital of Traditional Chinese Medicine; RenJi Hospital
• Treatments: Capecitabine; Docetaxel; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically proven gastric carcinoma with radical operation, TNM (primary tumor, regional nodes, metastasis) stage IIIb or IIIc （The Eighth Edition American Joint Committee on Cancer [AJCC] gastric cancer staging）;

• Karnofsky performance status higher than 70;

• Adequate hepatic, renal, cardio and hematologic function;

• With patients' consent and comply to long term follow-up.

Exclusion Criteria:

• Gastrectomy beyond D2, or TNM stage beyond Ⅲb and Ⅲc;

• Histological type beyond gastric carcinoma;

• Conversion chemotherapy before surgery;

• Concurrent cancer;

• Women of gravid or lactating; patients with mental illness;

• Uncontrolled significant comorbid conditions.