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

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

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

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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Radiation: Concurrent chemo-radiotherapy
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-75； Had histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction； ECOG 0-1； Subjects has to voluntarily join the study and sign the Informed Consent Form for the study; D2 and R0 resection; Locally advanced (UICC stage, T4, N2, N3) gastric cancer after surgery; More than 15 lymph nodes; 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: Previous radiotherapy or chemotherapy； Inadequate organ function; Pregnant or lactating women or women of childbearing potential.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All patients randomized to receive chemotherapy or chemo-radiotherapy after D2 surgery
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiotherapy, postoperative, gastric cancer