Ignite Creation Date:
2024-05-06 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03406299
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2018-01-07
Brief Title:
Phase II Randomized Trial of SLOG vs GC in Locally Advanced or Metastatic Biliary Tract Cancer
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
Phase II Randomized Trial of S-1 Leucovorin Oxaliplatin and Gemcitabine SLOG vs Gemcitabine and Cisplatin GC in Locally Advanced or Metastatic Biliary Tract Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
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:
To evaluate the following items in patients with locally advanced and metastatic biliary tract cancer receiving SLOG or GC treatment Primary objective 6-month progression-free survival rate
Secondary objectives
Objective response rate Disease control rate Objective response rate ORR stable disease 12 weeks Progression-free Survival Overall survival Safety profile Biomarker study
Secondary objectives
Objective response rate Disease control rate Objective response rate ORR stable disease 12 weeks Progression-free Survival Overall survival Safety profile Biomarker study
Detailed Description:
To evaluate the following items in patients with locally advanced and metastatic biliary tract cancer receiving SLOG or GC treatment Primary objective 6-month progression-free survival rate Secondary objectives Objective response rateDisease control rate Objective response rate ORR stable disease 12 weeksProgression-free Survival Overall survival Safety profileBiomarker study This is a randomized open-labeled two-arm multi-center phase II clinical study
Arm 1 SLOG regimen every 14 days as one cycle S-1 35 mgm2bid day 1 - 7 maximum dose 120 mgday Leucovorin 30 mgbid day 1-7 Oxaliplatin 85 mgm2 in 250 mL of 5 Glucose given as 2-hour intra- venous infusion day 1 Gemcitabine 800 mgm2 in 250 mL of normal saline given as fixed dose-rate FDR 10 mgm2min infusion day 1 After the administration of gemcitabine the infusion line should be flushed with 20 ml of normal saline and then 50 ml of 5 glucose solution before the administration of oxaliplatin
Arm2 GC regimen every 21 days as one cycle Gemcitabine 1000 mgm2 in 100 mL of normal saline IV drip for 30 mins on D1 and D8 Cisplatin 25 mgm2 in 250ml of normal saline IV drip for 2 hours on D1 and D8
Treatment will be stopped in case of progressive disease unacceptable toxicity patients refusal or death
Arm 1 SLOG regimen every 14 days as one cycle S-1 35 mgm2bid day 1 - 7 maximum dose 120 mgday Leucovorin 30 mgbid day 1-7 Oxaliplatin 85 mgm2 in 250 mL of 5 Glucose given as 2-hour intra- venous infusion day 1 Gemcitabine 800 mgm2 in 250 mL of normal saline given as fixed dose-rate FDR 10 mgm2min infusion day 1 After the administration of gemcitabine the infusion line should be flushed with 20 ml of normal saline and then 50 ml of 5 glucose solution before the administration of oxaliplatin
Arm2 GC regimen every 21 days as one cycle Gemcitabine 1000 mgm2 in 100 mL of normal saline IV drip for 30 mins on D1 and D8 Cisplatin 25 mgm2 in 250ml of normal saline IV drip for 2 hours on D1 and D8
Treatment will be stopped in case of progressive disease unacceptable toxicity patients refusal or death
Study Oversight
Has Oversight DMC:
None
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?:
None