Trial of Adjuvant XELOX Chemotherapy and Concurrent Capecitabine and Radiotherapy for Resected Gastric Carcinoma

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the trial is to compare disease-free survival between adjuvant XELOX alone vs XELOX with concurrent capecitabine and radiotherapy in curatively resected gastric cancer patients with D2 dissection.

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

Details

• Lead Sponsor: xie congying
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically proven gastric cancer; ≥ D2 resection

• Stage T3、4/N+

• 18 ≤ age ≤ 75

• Eastern Cooperative Oncology Group 0-2

• No distant metastasis

• Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)

• Adequate renal functions(serum creatinine ≤ 1.5mg/dl)

• Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)

• Written informed consent

Exclusion Criteria:

• Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer;

• Active infection requiring antibiotics;

• Pregnant, lactating women;

• Psychiatric illness, epileptic disorders;

• Concurrent systemic illness not appropriate for chemotherapy;

• Resection margin (+);

• History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma;

• D0, D1 resection;