Trial of Adjuvant XELOX Chemotherapy and Concurrent Capecitabine and Radiotherapy for Resected Gastric Carcinoma
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, radiotherapy, postoperative therapy, chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Histologically proven gastric cancer; ≥ D2 resection
- Stage T1-4, 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;
Sites / Locations
- The First Affiliated Hospital of Wenzhou Medical College
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
capecitabine/Oxaliplatin/radiotherapy
capecitabine/Oxaliplatin
sequence chemoradiotherapy following radical resection sequence chemoradiotherapy two cycles of XELOX + concurrent chemoradiotherapy + two cycles of XELOX. Postoperative radiotherapy regimen: Radiotherapy consisted of 4500 centigray of radiation at 180 centigray per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered. Concurrent chemotherapy regimen: capecitabine 825 mg/m² twice daily Postoperative chemotherapy regimen: see arm 2
chemotherapy alone following radical resection Drug: chemotherapy alone following radical resection Postoperative chemotherapy regimen: The XELOX regimen was administrated: Oxaliplatin, 130mg/m2/day on day1, i.v. 2h; Capecitabine 1000mg/m²/day twice daily d1-14; every 21 days repeated, for 4 cycles.