Phase III Trial of Adjuvant Chemo-radiotherapy After D2 Surgery of Gastric Cancer

July 25, 2018 updated by: Xianglin Yuan, Huazhong University of Science and Technology

A Randomized Phase III Trial of Postoperative Chemotherapy or Chemo-radiotherapy for Locally Advanced Gastric Cancer After D2 Resection

The purpose of this study is to explore the efficacy of adjuvant radiotherapy for D2 resected gastric cancer

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The radiotherapy dose of 45Gy in 25 fractions as adjuvant treatment after D2 surgery for gastric cancer

Study Type

Interventional

Enrollment (Anticipated)

408

Phase

  • Phase 3

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
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Xianglin Yuan, MD,PHD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ping Peng, MD,PHD

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. Aged 18-75；
  2. Had histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction；
  3. ECOG 0-1；
  4. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;
  5. D2 and R0 resection;
  6. Locally advanced (UICC stage, T4, N2, N3) gastric cancer after surgery;
  7. More than 15 lymph nodes;
  8. Adequate organ function as defined below: Hematologic ANC ≥ 2*109/L, Platelets ≥ 100*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.

Exclusion Criteria:

  1. Previous radiotherapy or chemotherapy；
  2. Inadequate organ function;
  3. Pregnant or lactating women or women of childbearing potential.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Chemotherapy
Adjuvant chemotherapy group receive 8 cycles of XELOX (Oxaliplatin 130mg/m2, ivdrip, D1,capecitabine 1000mg po, Bid, D1-14, Q21D)
Drug: Chemotherapy
Chemotherapy group receive 8 cycles of XELOX.
Experimental: Chemo-radiotherapy
Adjuvant chemo-radiotherapy group receive 6 cycles of XELOX (Oxaliplatin 130mg/m2, ivdrip, D1, capecitabine 1000mg po, Bid, D1-14, Q21D) and concurrent chemo-radiotherapy (capecitabine 825mg po, Bid, d1-5, QW)
Radiation: Concurrent chemo-radiotherapy
Experimental group receive 6 cycles of XELOX chemotherapy and concurrent chemo-radiotherapy. The radiotherapy dose of 45Gy in 25 fractions delivered by IMRT Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS
Time Frame: 36 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 36 months
From date of randomization until the date of first documented death from any cause, assessed up to 36 months
36 months

Collaborators and Investigators

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

Sponsor

Huazhong University of Science and Technology

Investigators

  • Study Chair: Xianglin Yuan, MD,PhD, Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

July 28, 2018

Primary Completion (Anticipated)

July 28, 2020

Study Completion (Anticipated)

July 28, 2022

Study Registration Dates

First Submitted

July 15, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 25, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJCC007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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