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Trial Title:
Neoadjuvant Chemoradiotherapy vs. Chemotherapy With Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer
NCT ID:
NCT01815853
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Neoadjuvant
Chemoradiotherapy
Chemotherapy
Locally advanced gastric cancer
Pathological complete response
D2 gastrectomy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Neoadjuvant Chemoradiotherapy versus Neoadjuvant Chemotherapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Neoadjuvant Chemoradiotherapy
Description:
Radiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 +
Oxaliplatin 130mg/m2 d1; 21-days/cycle)
Arm group label:
Neoadjuvant Chemoradiotherapy
Intervention type:
Drug
Intervention name:
Neoadjuvant Chemotherapy
Description:
3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1;
21-days/cycle)
Arm group label:
Neoadjuvant Chemotherapy
Intervention type:
Procedure
Intervention name:
R0 D2 Gastrectomy
Arm group label:
Neoadjuvant Chemoradiotherapy
Arm group label:
Neoadjuvant Chemotherapy
Intervention type:
Drug
Intervention name:
Adjuvant Chemotherapy
Description:
3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1;
21-days/cycle)
Arm group label:
Neoadjuvant Chemoradiotherapy
Arm group label:
Neoadjuvant Chemotherapy
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Wang, M.D, Ph.D
Phone:
0086-20-87343910
Email:
wangwei@sysucc.org.cn
Investigator:
Last name:
Zhi-wei Zhou, MD,PhD
Email:
Principal Investigator
Start date:
June 2013
Completion date:
December 2025
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Anhui Medical University
Agency class:
Other
Collaborator:
Agency:
Liaoning Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Guangxi Medical University Cancer Center
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
First Hospital of China Medical University
Agency class:
Other
Collaborator:
Agency:
First People's Hospital of Hangzhou
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01815853
