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

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ClinicalTrials.gov Identifier: NCT03601988
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Xianglin Yuan, Huazhong University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Radiation: Concurrent chemo-radiotherapy Drug: Chemotherapy Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All patients randomized to receive chemotherapy or chemo-radiotherapy after D2 surgery
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of Postoperative Chemotherapy or Chemo-radiotherapy for Locally Advanced Gastric Cancer After D2 Resection
Estimated Study Start Date : July 28, 2018
Estimated Primary Completion Date : July 28, 2020
Estimated Study Completion Date : July 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. OS [ Time Frame: 36 months ]
    From date of randomization until the date of first documented death from any cause, assessed up to 36 months



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601988


Contacts
Contact: Xianglin Yuan, MD,PhD 8627-83663406 xlyuan1020@163.com
Contact: Ping Peng, PhD,MD 8627-83663407 pengpingtj@163.com

Locations
China, Hubei
Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Xianglin Yuan, MD,PHD    8627-83663406 ext 1    xlyuan1020@163.com   
Contact: Ping Peng, MD,PHD    8627-83663407 ext 1    pengpingtj@163.com   
Principal Investigator: Xianglin Yuan, MD,PHD         
Sub-Investigator: Ping Peng, MD,PHD         
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Study Chair: Xianglin Yuan, MD,PhD Tongji Hospital

Publications:

Responsible Party: Xianglin Yuan, Professor, Head of the cancer center, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03601988     History of Changes
Other Study ID Numbers: TJCC007
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xianglin Yuan, Huazhong University of Science and Technology:
gastric cancer
radiotherapy
postoperative

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases