Status:
COMPLETED
A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Stomach Neoplasms
Neoadjuvant Therapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This prospective, randomized phase II study is designed to evaluate weather neoadjuvant chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and postoperative chemot...
Eligibility Criteria
Inclusion
- Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as cT3-4N0M0 or anyTN+M0
- 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
- Any prior chemotherapy or other cancer treatment prior to this protocol
- 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 or Xeloda or Oxaliplatin
- 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 :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT02301481
Start Date
January 1 2014
End Date
December 1 2017
Last Update
October 16 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, China, 100021