Trial Outcomes & Findings for A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients With Gastric or GEJ Cancer (NCT NCT05567835)
NCT ID: NCT05567835
Last Updated: 2026-04-09
Results Overview
ArmA has all 4 cycles of FLOT given prior to surgery and ArmB has 2 cycles of pre-operative FLOT and 2 cycles of post-operative FLOT. Each cycle consists of 28 days and consists of 2 chemotherapy sessions given every 14 days. The completion rate of participants is presented based on the number of participants who have completed all treatments by their arms.
TERMINATED
PHASE2
3 participants
at week 16 for Arm A and at week 24 for Arm B
2026-04-09
Participant Flow
Since activation, 3 subjects were enrolled but were not able to be randomized to a treatment arm because of a positive diagnostic laparoscopy result. Given the lack of accrual the study was closed
Participant milestones
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Arm A: FLOT-TNT ( Investigational Arm)
Arm A is the investigational arm with all 4 cycles of FLOT given as total neoadjuvant chemotherapy prior to surgery. Each cycle is 28 days and consists of 2 chemotherapy sessions given every 14 days. The total number of chemotherapy sessions in Arm A is 8. Every effort will be made to have surgery in week 20 ( -1 to +2 weeks), 4 weeks post C4 on arm A.
Fluorouracil: 2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15
Leucovorin: 200 mg mg/m2 IV over 2 hours Day 1,15
Oxaliplatin: 85 mg/m2 IV over 2 hours Day 1,15
Docetaxel: 60 mg/m2 IV over 60 minutes Day 1,15
GSCF: Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16
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Arm B: FLOT-POP ( Standard Arm)
Arm B us the standard perioperative arm with 2 cycles of pre-operative FLOT ( 4 treatment sessions) and 2 cycles ( 4 treatment sessions) of post-operative FLOT. Post-surgery FLOT will start 4-6 weeks post surgery. Each cycle of chemotherapy consists of 28 days and consists of 2 chemotherapy sessions given every 14 days. The total number of chemotherapy sessions in arm B is 8. Every effort should be done to have surgery done in week 12 ( -1 to +2 weeks) post completion of cycle 2 on ARM B.
Fluorouracil: 2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15
Leucovorin: 200 mg mg/m2 IV over 2 hours Day 1,15
Oxaliplatin: 85 mg/m2 IV over 2 hours Day 1,15
Docetaxel: 60 mg/m2 IV over 60 minutes Day 1,15
GSCF: Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16
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Overall Study
STARTED
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0
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients With Gastric or GEJ Cancer
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: at week 16 for Arm A and at week 24 for Arm BPopulation: We could not report data in the table because all subjects that signed consent (and were thus considered enrolled per the federal definition of research participant) did not meet protocol inclusion criteria and data were not collected because all enrolled participants did not start the study.
ArmA has all 4 cycles of FLOT given prior to surgery and ArmB has 2 cycles of pre-operative FLOT and 2 cycles of post-operative FLOT. Each cycle consists of 28 days and consists of 2 chemotherapy sessions given every 14 days. The completion rate of participants is presented based on the number of participants who have completed all treatments by their arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at week 12 for Arm A and at week 20 for Arm BPopulation: We could not report data in the table because all subjects that signed consent (and were thus considered enrolled per the federal definition of research participant) did not meet protocol inclusion criteria and data were not collected because all enrolled participants did not start the study.
The pathological response will be evaluated by using Mandard tumor regression grade (TRG) in the primary tumor. Mandard TRG score is from TRG0 (complete response), TRG1 (near-complete response), TRG2 (partial response), and TRG3 (poor or no response).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at week 12 for Arm A and at week 20 for Arm BPopulation: We could not report data in the table because all subjects that signed consent (and were thus considered enrolled per the federal definition of research participant) did not meet protocol inclusion criteria and data were not collected because all enrolled participants did not start the study.
Pathologic nodal stage is assessed post gastrectomy surgery and an ordinal variable. Nodal status is assessed as positive or negative on pathology. The number of positive lymph nodes is obtained from post gastrectomy surgical specimens.
Outcome measures
Outcome data not reported
Adverse Events
Arm A: FLOT-TNT ( Investigational Arm)
Arm B: FLOT-POP ( Standard Arm)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place