Phase III Randomized Trial of Adjuvant XP Chemotherapy and XP/RT for Resected Gastric Adenocarcinoma

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the trial is to compare disease-free survival between adjuvant capecitabine/cisplatin alone vs capecitabine/cisplatin with radiotherapy (chemoradiation) in curatively resected gastric cancer patients.

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

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Capecitabine; Cisplatin

Criteria

Inclusion Criteria:

1. Histologically proven gastric adenocarcinoma

2. ≥ D2 resection

3. Stage IB(T1N1,T2bN0), II, IIIA, IIIB, IV(T4,N3 포함, M1 lymph node 제외)

4. 18 ≤ age ≤ 75

5. ECOG 0-2

6. No distant metastasis

7. Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl)

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

9. liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)

10. Written informed consent

Exclusion Criteria:

1. Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer

2. Active infection requiring antibiotics

3. Pregnant, lactating women

4. Psychiatric illness, epileptic disorders

5. Concurrent systemic illness not appropriate for chemotherapy

6. Resection margin (+)

7. Pathologic stage IA

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

9. M1 lymph node (+)

10. D0, D1 resection