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

November 19, 2014 updated by: Wang Xin, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Recruiting
        • Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-1 based chemoradiotherapy
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner.
Radiation: intensity-modulated radiotherapy
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.
Drug: S-1
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years
Disease free survival
Time Frame: 3 years
3 years
Distant metastasis free survival
Time Frame: 3 years
3 years
Locoregional recurrence free survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of dosimetric differences between radiation techniques
Time Frame: 1 year
To compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2013RE-088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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