A Phase 3 interventional study of Docetaxel;oxaliplatin;s1 and oxaliplatin;s1 in Gastric Adenocarcinoma, sponsored by Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-08-10.
Sponsored by Chinese Academy of Medical Sciences · Phase 3, Interventional, and Treatment
gastric cancer is a highly aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the 5-year survival of neoadjuvant S1, oxaliplatin, and docetaxel (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable gastric/esophagogastric junction (EGJ) cancer.
Two arms, phase 3 study of neoadjuvant S1, oxaliplatin, and docetaxel (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable gastric/esophagogastric junction (EGJ) cancer. 380 Patients will be enrolled in this trial. The primary objective of this study is to determine the 5-year survival of the two arms.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 380 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
4 cycles preoperative chemotherapy with Docetaxel+oxaliplatin+s1 . Gastric resection. 6 cycles adjuvant chemotherapy with sequential oxaliplatin+s1 or oxaliplatin+s1,then s1 for 6 months。
Drug: Docetaxel;oxaliplatin;s1
3 cycles preoperative chemotherapy with oxaliplatin+s1. Gastric resection. 4 cycles adjuvant chemotherapy with sequential oxaliplatin+s1
Drug: oxaliplatin;s1
Docetaxel 60mg/m2 was administered on day 1 of every 14 days.oxaliplatin 85 mg/m2 was administered on day 2 every 14 days. 40-60 mg of oral S-1 according to body-surface area twice a day was given for 10 days every 14 days .
oxaliplatin 100 mg/m2 on day 1 every 21 days.40-60 mg of oral S-1 according to body-surface area twice a day was given for 2 weeks every 21 days .
5 year overall survival
Time frame: 6 years
3 year relapse free survival
Time frame: 5 years
Surgical complete resection rate (R0)
Time frame: 2.5 year
Pathological response rate
Time frame: 2.5 year
quality of life questionnaire
Time frame: 6 year
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Medical Sciences