Pre-operative Chemoradiotherapy or Chemotherapy Following Surgery and Adjuvent Chemotherapy in Patients With Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
pre-operative,, chemoradiotherapy,, chemotherapy,, treatment, outcome
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pre-operative chemoradiotherapy Type: Radiation
Name: Capecitabine,Oxaliplatin Type: Drug
Overall Status
Recruiting
Summary
Background: It has been shown that the patitents with gastric cancer could benefits from peri-operative chemoradiotherapy, but whether the pre-operative chemoradiotherapy can improve patitents' outcome is still unclear.

Patients and methods: In this study , patients with histologically confirmed gastric cancer whose pre-operative staging are cT4 any N,MO, aged from 18 to 70 years and with Eastern Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized 1:1 to receive pre-operative chemoradiotherapy with DT45Gy/25f plus two cycles of XELOX(Xeloda 1000mg/m2, BID, DI-D14; Oxaliplatin 130mg/m2 on day 1;,21-days per cycle) or chemotherapy alone then following by surgical resection and adjuvant chemotherapy with XELOX at the same dose up to 4 cycles. The primary end point is overall survival (OS), and secondary end point is disease free survival(DFS) and safety. Final study analysis will be conducted in the end of the 5th year after the last patient's enrollment.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- informed consensus of patients

- be able to receive oral administration

- from 18 to 70 years old

- be proven to be primary adenocarcinoma of gastric cancer and pre-operative staging cT4, any N,MO,

- without other chemotherapy and/or radiation against to the disease

- normal function of other 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 xeloda or oxaliplatin

- be enrolling in other clinical trials

- abnormal GI tract function

- dysfunction of other organs

- female in pregnancy or lactation,or refuse to receive Contraception measures during chemotherapy

- other situation to be judged not adaptive to the study by investigators
Location
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Xiao-wei Sun, MD - 86-20-87343123 - sunxw@sysucc.org.cn
Start Date
July 2012
Sponsors
Sun Yat-sen University
Source
Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page