Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT03961867
Status:
UNKNOWN
Last Update Posted:
2021-06-01
First Post:
2019-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Docetaxel Versus Oxaliplatin as Addition to S-1 for Stage II / III Gastric Adenocarcinoma
Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Organization:
Study Overview
Official Title:
S-1 Plus Docetaxel(DS) Versus S-1 Plus Oxaliplatin(SOX) as Postoperative Therapy for Stage II / III Gastric Cancer, a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
S-1 plus oxaliplatin has been proved better than S-1 alone for stage II or III gastric cancer.
Docetaxel also showed excellent efficacy with S-1 in the postoperative setting for stage III gastric cancer.
This trial is designed to investigate the efficacy and safety of S-1 plus docetaxel versus S-1 plus oxalipltin as adjuvant chemotherapy after D2 resection in stage II / III gastric cancer.
Docetaxel also showed excellent efficacy with S-1 in the postoperative setting for stage III gastric cancer.
This trial is designed to investigate the efficacy and safety of S-1 plus docetaxel versus S-1 plus oxalipltin as adjuvant chemotherapy after D2 resection in stage II / III gastric cancer.
Detailed Description:
In this study, patients with gastric or EGJ adenocarcinoma who received D2 dissection and staged II or III, aged from 18 to 75 years and with ECOG PS ≤2 and adequate organ function, are stratified randomized according to pstage and location of primary lesion.
Group DS:
S-1 is orally administer by BSA (\<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \>1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.
Docetaxel 40mg/m2/3w from the second to the seventh cycles.
Group SOX:
S-1 is orally administer by BSA (\<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \>1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.
Oxaliplatin 130mg/m2/3w from the first to the eight cycles.
The primary end point is disease-free survival(DFS). The overall survival (OS), safty and quality of life are secondary end points.
Group DS:
S-1 is orally administer by BSA (\<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \>1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.
Docetaxel 40mg/m2/3w from the second to the seventh cycles.
Group SOX:
S-1 is orally administer by BSA (\<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \>1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.
Oxaliplatin 130mg/m2/3w from the first to the eight cycles.
The primary end point is disease-free survival(DFS). The overall survival (OS), safty and quality of life are secondary end points.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: