A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma
Conditions
Stomach Neoplasms - Neoadjuvant Therapy - Chemoradiotherapy - Chemotherapy
Conditions: official terms
Adenocarcinoma - Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: SIB-IMRT Type: Radiation
Name: S-1 Type: Drug
Name: Surgery Type: Procedure
Name: SOX Type: Drug
Overall Status
Recruiting
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 chemotherapy for locally advanced gastric adenocarcinoma.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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 Criteria:

- 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
Location
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, China
Status: Recruiting
Contact: Xin Wang, MD - +8613311583220 - beryl_wx2000@163.com
Start Date
January 2014
Completion Date
December 2018
Sponsors
Chinese Academy of Medical Sciences
Source
Chinese Academy of Medical Sciences
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page