Status:
COMPLETED
Phase III Randomized Trial of Adjuvant XP Chemotherapy and XP/RT for Resected Gastric Adenocarcinoma
Lead Sponsor:
Samsung Medical Center
Conditions:
Gastric Cancer
Surgery
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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...
Detailed Description
Although gastrectomy is the only potentially curative treatment in gastric cancer patients, the overall survival results remain unsatisfactory. The main factor accounting for high mortality rate is th...
Eligibility Criteria
Inclusion
- Histologically proven gastric adenocarcinoma
- ≥ D2 resection
- Stage IB(T1N1,T2bN0), II, IIIA, IIIB, IV(T4,N3 포함, M1 lymph node 제외)
- 18 ≤ age ≤ 75
- ECOG 0-2
- No distant metastasis
- Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl)
- Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
- liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)
- Written informed consent
Exclusion
- 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 (+)
- Pathologic stage IA
- History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma
- M1 lymph node (+)
- D0, D1 resection
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT00323830
Start Date
October 1 2004
End Date
April 1 2011
Last Update
November 9 2011
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea