Neoadjuvant Chemoradiotherapy vs. Chemotherapy With Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer

Study Overview
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Brief Summary
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Patients with histologically confirmed gastric adenocarcinoma with locally advanced gastric cancer are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy or neoadjuvant chemotherapy alone using XELOX regimen following D2 gastrectomy and adjuvant chemotherapy for 3 cycles. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety.

Detailed Description
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Background: Literatures have shown that patitents with locally advanced gastric cancer could potentially benefit from neoadjuvant chemoradiotherapy, but whether this can improve patitents' outcome is still unclear. Patients and methods: In this study , patients with histologically confirmed gastric adenocarcinoma with pre-operative staging are cT3N2/N3M0, cT4aN+M0 and cT4bNanyM0, aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy (Capecitabine 1000mg/m2, BID, D1-14; Oxaliplatin 130mg/m2 on day 1 for a 21-day cycle) or neoadjuvant chemotherapy alone using XELOX regimen following by D2 gastrectomy and adjuvant chemotherapy with same dosage of XELOX therapy for up to 3 cycles. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.

Official Title
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An Randomized, Multicenter, Open-label, Phase III Trial Comparing Neoadjuvant Chemoradiotherapy Versus Chemotherapy in Patients With Locally Advanced Gastric Adenocarcinoma

Conditions
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Gastric Cancer

Intervention / Treatment
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* Radiation: Neoadjuvant Chemoradiotherapy
* Drug: Neoadjuvant Chemotherapy
* Procedure: R0 D2 Gastrectomy
* Drug: Adjuvant Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consensus of the enrolled patients being able to receive oral drug from 18 to 75 years old proven to be primary adenocarcinoma of gastric cancer and pre-operative staging cT3N2/N3M0, cT4aN+M0, cT4bNanyM0, no prior other chemotherapy and/or radiation against the disease normal function of all other vital organs including heart,liver ,kidney and so on Eastern Cooperative Oncology Group performance status: 0 2 Exclusion Criteria: history of other malignancy allergic reaction to capecitabine or oxaliplatin enrolled in other clinical trials abnormal GI tract function dysfunction of other organs pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy other situations judged as not adaptive to the study by investigators

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: Neoadjuvant Chemoradiotherapy versus Neoadjuvant Chemotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant Chemoradiotherapy<br>Radiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 D1; 21-days/cycle) following with D2 Gastrectomy and 3 cycles of Adjuvant XELOX Chemotherapy | Radiation: Neoadjuvant Chemoradiotherapy<br>* Radiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)<br>Procedure: R0 D2 Gastrectomy<br> <br> Drug: Adjuvant Chemotherapy<br>* 3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)<br>|
| Active Comparator: Neoadjuvant Chemotherapy<br>3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 D1; 21-days/cycle) following with D2 Gastrectomy and 3 cycles of Adjuvant XELOX Chemotherapy | Drug: Neoadjuvant Chemotherapy<br>* 3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)<br>Procedure: R0 D2 Gastrectomy<br> <br> Drug: Adjuvant Chemotherapy<br>* 3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival | 3-year DFS | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | 5-year Overall Survival | 5 years | 
| Pathological Complete Remission | pCR | Peri-operative period | 
| Radical Resection Rate | R0 Resection Rate | Peri-operative period | 
| Adverse effects | Treatment safety | Peri-operative period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoadjuvant, Chemoradiotherapy, Chemotherapy, Locally advanced gastric cancer, Pathological complete response, D2 gastrectomy