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

Study Overview
=================
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 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.

Official Title
-----------------
A Phase II Trial of Intensity-Modulated Radiotherapy Combined With S-1 Based Chemotherapy in Completely Resected Gastric Cancer

Conditions
-----------------
Stomach Neoplasms, Chemoradiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated

Intervention / Treatment
-----------------
* Radiation: intensity-modulated radiotherapy
* Drug: S-1


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-1 based chemoradiotherapy<br>S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner. | Radiation: intensity-modulated radiotherapy<br>* A total irradiation dose of 45 Gy was delivered in daily 1.8-Gy fractions (5 days a week over 5 weeks) to all patients.<br>Drug: S-1<br>* S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 3 years | 
| Locoregional recurrence free survival |  | 3 years | 
| Overall survival |  | 3 years | 
| Distant metastasis free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemoradiotherapy-induced toxicities assessed by CTCAE 4.0 |  | during treatment and within the first 30 days after completion of chemoradiotherapy |