Overview

A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma

Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chinese Academy of Medical Sciences
Treatments:
Oxaliplatin
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