Status:
UNKNOWN
A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Stomach Neoplasms
Chemoradiotherapy, Adjuvant
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The aim of this phase II trial was to evaluate the feasibility, efficacy and tolerability of intensity-modulated radiotherapy combined with S-1 based chemotherapy in patients with pathologically posit...
Eligibility Criteria
Inclusion
- Pathologically proven positive lymph node gastric adenocarcinoma in patients undergoing R0 resection
- Any prior chemotherapy is allowed in this protocol
- No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation
- No prior abdominal or pelvic radiotherapy
- Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months
- Patients must have normal organ and marrow function as defined below:
- Leukocytes greater than or equal to 3,000 G/L
- Platelets: greater than or equal to 100,000/mm3
- Hemoglobin:greater than or equal to 10g/L
- Total bilirubin: within normal institutional limits
- AST/ALT: less than or equal to 1.5 times the upper limit
- Creatinine within normal upper limits
- Informed consent
Exclusion
- Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
- With any distant metastasis in liver,lung,,bone,CNS,or peritoneal transplantation
- History of allergic reactions attributed to similar chemical or biologic complex to S-1
- Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
- History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
- History of prior radiation to the abdomen
- Pregnant or lactating females
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02296658
Start Date
January 1 2014
End Date
December 1 2016
Last Update
November 20 2014
Active Locations (1)
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1
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, China, 100021