This is a randomized pilot study to evaluate and to compare the completion rates of Total Neoadjuvant chemotherapy with FLOT ( FLOT-TNT) and perioperative chemotherapy with FLOT ( FLOT-POP).
Participants will be randomized 1:1 to either total Neoadjuvant chemotherapy with with FLOT-TNT ( all 4 cycles of chemotherapy before surgery) or standard of care FLOT-POP ( 2 cycles of chemotherapy before surgery and 2 cycles of chemotherapy after surgery). Each cycle of chemo is 28 days long with chemo administered on Days 1 and Day 15 of the cycle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15
200 mg mg/m2 IV over 2 hours Day 1,15
85 mg/m2 IV over 2 hours Day 1,15
Baylor College of Medicine Medical Center - McNair Campus
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Baylor St. Luke's Medical Center
Houston, Texas, United States
Ben Taub Hospital
Houston, Texas, United States
Completion rate of Participants who have completed their all-allocated treatments, either Arm A: FLOT-TNT or Arm B: FLOT-POP
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.
Time frame: at week 16 for Arm A and at week 24 for Arm B
Pathologic response rate
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).
Time frame: at week 12 for Arm A and at week 20 for Arm B
Number of positive lymph nodes
Nodal status is assessed as positive or negative on pathology. The number of positive lymph nodes is obtained from post gastrectomy surgical specimens.
Time frame: at week 12 for Arm A and at week 20 for Arm B
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
60 mg/m2 IV over 60 minutes Day 1,15
Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16
Harris Health System- Smith Clinic
Houston, Texas, United States