Phase II Clinical Trial of Docetaxel Plus Cisplatin as Adjuvant Chemotherapy and Concurrent Chemoradiotherapy Versus FOLFOX6 as Adjuvant and 5-FU/CF as Chemoradiotherapy in Patients of Locally Advanced Gastric Cancer After Radical Surgery
In Intergroup 0116 trial, 5-FU plus CF regimen was used as adjuvant chemotherapy and
concurrent chemoradiotherapy in patients with resected gastric cancer.But 33 percent of
those in the chemoradiotherapy group had distant relapses. Docetaxel plus cisplatin regimen
as adjuvant chemotherapy for gastric cancer has been proofed Safe and Effective in many
clinical trials about gastric cancer. The purpose of this study is to evaluate efficacy and
safety of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent
chemoradiotherapy regimen compared with classical FOLFOX6 regimen as adjuvant chemotherapy
and 5-FU/CF as chemoradiotherapy in patients of locally advanced gastric cancer after D2
radical surgery. The investigators hope the new interventions can reduce the rate of distant
metastasis and have more clinical benefit.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free survival
efficacy of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as 2 or 3 year disease free survival
2,3 year
No
Y F Zhou, PHD
Principal Investigator
President of Zhongnan Hospital of Wuhan University
China: Food and Drug Administration
HCCSC G-02
NCT01889303
May 2013
June 2016
Name | Location |
---|