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

Gastric Cancer Clinical Trial

— Neo-CRAG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01815853
• Other study ID #: SYSUCCGPS2
• Status: Recruiting
• Phase: Phase 3
• Start date: June 2013
• Est. completion date: December 2025

Study information

• Verified date: August 2018
• Source: Sun Yat-sen University
• Contact: Zhi-wei Zhou, M.D, Ph.D
• Phone: 0086-20-87343626
• Email: zhouzhw[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 620
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Radiation:
• Neoadjuvant Chemoradiotherapy
Radiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)

Drug:
• Neoadjuvant Chemotherapy
3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)

Procedure:
• R0 D2 Gastrectomy

Drug:
• Adjuvant Chemotherapy
3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (10)

Lead Sponsor	Collaborator
Sun Yat-sen University	First Affiliated Hospital of Anhui Medical University, First Hospital of China Medical University, First People's Hospital of Hangzhou, Guangdong General Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangxi Medical University Cancer Center, Liaoning Cancer Hospital & Institute, Tianjin Medical University Cancer Institute & Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free Survival	3-year DFS	3 years
Secondary	Overall Survival	5-year Overall Survival	5 years
Secondary	Pathological Complete Remission	pCR	Peri-operative period
Secondary	Radical Resection Rate	R0 Resection Rate	Peri-operative period
Secondary	Adverse effects	Treatment safety	Peri-operative period