A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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 positive lymph node after completely resected gastric cancer. Furthermore, the investigators sought to compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning for gastric cancer as adjuvant radiotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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