Ignite Creation Date:
2024-05-06 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03606928
Status:
COMPLETED
Last Update Posted:
2020-03-20
First Post:
2018-07-22
Brief Title:
mFLOT Chemotherapy as First-line Treatment in GC
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
Modified FLOT Chemotherapy as First-line Treatment in Advanced or Metastatic Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2020-03
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:
A single center phase 1b2 trail to identified suitable dosage and its efficacy of modified FLOT regime in Chinese gastric cancer patients This trial is designed to identified recommended phase II dose RP2D of modified FLOT in Chinese patients and to evaluate the efficacy of modified FLOT regime as first-line for advanced or metastatic gastric cancer
This trial is in 2 stages the first stage will establish the maximum tolerated dose MTD and RP2D of docetaxel and oxaliplatin in FLOT regime In the second stage the efficacy of modified FLOT will be assessed by response rate
This trial is in 2 stages the first stage will establish the maximum tolerated dose MTD and RP2D of docetaxel and oxaliplatin in FLOT regime In the second stage the efficacy of modified FLOT will be assessed by response rate
Detailed Description:
The RP2D of FLOT regime will be established with a standard 33 design starting with the dose of 40mgm2 docetaxel dose level 1 and 65mgm2 oxaliplatin dose level 1 The plan of dose escalation will be found in following table Chemotherapy will be administered two-weekly maximum 12 cycles until progression of disease intolerable toxicity or withdraw of patients
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