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

Phase 2

• Conditions: Stomach Neoplasms; Radiotherapy, Intensity-Modulated; Chemoradiotherapy, Adjuvant
• Interventions: Radiation: intensity-modulated radiotherapy; Drug: S-1

• Registration Number: NCT02296658
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-11
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-11-19
• Last Update Submitted: 2014-11-19
• Study First Posted: 2014-11-20
• Last Update Posted: 2014-11-20
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S-1 based chemoradiotherapy	S-1	S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner.
S-1 based chemoradiotherapy	intensity-modulated radiotherapy	S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner.

Primary Outcome Measures

Name	Time	Method
Locoregional recurrence free survival	3 years
Distant metastasis free survival	3 years
Overall survival	3 years
Disease free survival	3 years

Secondary Outcome Measures

Name	Time	Method
Chemoradiotherapy-induced toxicities assessed by CTCAE 4.0	during treatment and within the first 30 days after completion of chemoradiotherapy

Trial Locations

Locations (1)

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC); 🇨🇳 Beijing, China