Postoperative IMRT Combined With Capecitabine for Advanced Gastric Cancer Patients

February 3, 2015 updated by: Jing Jin, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase II Study of Postoperative Intensity-modulated Radiotherapy (IMRT) Combined With Capecitabine for Stage II/III Gastric Cancer Patients

Radiation therapy plus concurrent chemotherapy has been demonstrated a significant improvement in overall and disease-free survival according to Intergroup Trial 0116 in patients with gastric cancer after surgical complete resection. Advantage of application of IMRT has been shown in planning comparison studies for postoperative gastric patients. So the investigators designed the trial to see safety and efficacy of postoperative concurrent chemoradiotherapy of capecitabine combined with IMRT for stage II/II gastric cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In Intergroup 0116, only 64% patients in concurrent chemoradiation group completed treatment as planed, but in recently reported ARTIST trial, capecitabine was admitted to concurrent with radiotherapy,patients who completed treatment as planed in concurrent group reach high as 80%. IMRT is an advanced radiotherapy technology which allows high conformal dose distribution to Planing Tumor Volume (PTV) and low dose to organ at risk. The purpose of this study is to evaluate feasibility and efficacy of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients after D1/2 surgery.

Study Type

Interventional

Enrollment (Anticipated)

40

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
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Dept of Radiation oncology, Cancer Hospital , Chinese Academy of Medical Science
        • Principal Investigator:
          • jing jin, professor
        • Contact:
        • 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:

  1. Postoperative histologically confirmed advanced adenocarcinoma of the stomach or the gastroesophageal junction.
  2. Age of 18 to 75, Karnofsky score higher than 70.
  3. Postoperative histologically conformed metastasis in perigastric lymph nodes and/or tumor invasion to muscularis propria or subserosa, without positive incisal margin. Stage II/III(AJCC 7th).
  4. No severe functional damage of major organ, normal blood cell, normal liver and kidney function.
  5. No clinical findings of distant metastasis.

  6. Predictive survival time longer than 6 months.

    -

Exclusion Criteria:

  1. Peritoneal carcinomatosis, as diagnosed by mandatory laparoscopy or distant metastasis
  2. Concurrent treatment with other experimental drugs or other anti-cancer therapy, or treatment within a clinical trial within 30 days prior to trial entry
  3. Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, no myocardial infarction within the last 12 months, unstable angina pectoris, or significant arrhythmia)
  4. Active or uncontrolled infection.
  5. Definitive contraindications for the use of corticosteroids as premedication
  6. Prior systemic (chemo- or targeted) treatment. Prior radiotherapy to the upper abdomen
  7. Any contraindication to treatment with cetuximab, capecitabine or cisplatin
  8. Previous malignancy within 5 years, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
  9. Known hypersensitivity against any of the study drugs ( capecitabine)

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: concurrent chemoradiation

• Radiation: concurrent chemoradiotherapy Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed tomographic (CT) simulation. Radiation was delivered with 6MV photons. Radiotherapy consisted of 4500 cGy of radiation at 180 cGy per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered.

Postoperative current chemotherapy regimen: capecitabine( 1,600 mg/m2 per day for 5 weeks).
Radiation: concurrent chemoradiation

postoperative Intensity-modulated radiotherapy (IMRT) combined with capecitabine for high risk gastric cancer patients Radiation: concurrent chemoradiotherapy Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed tomographic (CT) simulation. Radiation was delivered with 6MV photons. Radiotherapy consisted of 4500 cGy of radiation at 180 cGy per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered.

Postoperative chemotherapy regimen: capecitabine( 1,600 mg/m2 per day for 5 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients
Time Frame: 3 months after concurrent chemoradiation
feasibility of concurrent IMRT combined with capecitabine is defined as toxicities (CTC-AE 3.0) and rate of patients complete concurrent chemoradiation according to protocol.
3 months after concurrent chemoradiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients
Time Frame: 3 years after concurrent chemoradiation
efficacy of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients in this trial is defined as 3-year overall survival and 3-year relapse free survival.
3 years after concurrent chemoradiation

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

Investigators

  • Principal Investigator: jing jin, professor, Cancer Hospital, Chinese Academy of Medical Science

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

October 1, 2011

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 26, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

February 5, 2015

Last Update Submitted That Met QC Criteria

February 3, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011 CH-GI-024

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.

Clinical Trials on Gastric Cancer

Clinical Trials on concurrent chemoradiation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe