Status:
COMPLETED
Postoperative Chemoradiotherapy With S-1 in Gastric Cancer
Lead Sponsor:
Chonnam National University Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.
Detailed Description
Surgery is the only possible curative treatment of gastric cancer. However, the high recurrence rate makes gastric cancer a disease difficult to cure by surgery alone. Despite the benefit of CRT on lo...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Histologically proven gastric adenocarcinoma which is complete resected
- ECOG performance status of 1 or lower
- Adequate bone marrow function
- absolute neutrophil count \[ANC\] ≥1,500µL, and platelets ≥100,000/µL
- Adequate kidney function (serum creatinine \< 1.5 mg/dL)
- Adequate liver function (serum total bilirubin \< 2 times the upper normal limit (UNL) serum transaminases levels \<2 times UNL
- No prior chemotherapy
Exclusion
- Other tumor type than adenocarcinoma
- Evidence of distant metastasis
- Past or concurrent history of neoplasm except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Uncontrolled infection
- Unstable cardiac disease despite treatment, myocardial infarction within months prior to study entry
- History of significant neurologic or psychiatric disorders including dementia or seizures
- Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- Symptoms of gastrointestinal obstruction
- concomitant drug medication: The following drugs cause drug interaction with S-1.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01824004
Start Date
April 1 2009
End Date
June 1 2012
Last Update
April 4 2013
Active Locations (1)
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1
Chonnam National University Hwasun Hospital
Hwasun-Eup, Jeollanam-do, South Korea, 519-809