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

Phase 3

Recruiting

• Conditions: Gastric Cancer
• Interventions: Radiation: Neoadjuvant Chemoradiotherapy; Drug: Neoadjuvant Chemotherapy; Procedure: R0 D2 Gastrectomy; Drug: Adjuvant Chemotherapy

• Registration Number: NCT01815853
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-21
• Study Start: 2013-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31
• Primary Completion: 2023-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 620

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoadjuvant Chemoradiotherapy	Neoadjuvant Chemoradiotherapy	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
Neoadjuvant Chemoradiotherapy	R0 D2 Gastrectomy	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
Neoadjuvant Chemoradiotherapy	Adjuvant Chemotherapy	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
Neoadjuvant Chemotherapy	Neoadjuvant Chemotherapy	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
Neoadjuvant Chemotherapy	R0 D2 Gastrectomy	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
Neoadjuvant Chemotherapy	Adjuvant Chemotherapy	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

Primary Outcome Measures

Name	Time	Method
Disease-free Survival	3 years	3-year DFS

Secondary Outcome Measures

Name	Time	Method
Overall Survival	5 years	5-year Overall Survival
Pathological Complete Remission	Peri-operative period	pCR
Radical Resection Rate	Peri-operative period	R0 Resection Rate
Adverse effects	Peri-operative period	Treatment safety

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China