NCT05567835

A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients With Gastric or GEJ Cancer

A Randomized, Open Labeled Phase II Pilot Study of Total Neoadjuvant Chemotherapy With FLOT ( FLOT-TNT) VS Standard Perioperative FLOT ( FLOTPOP) in Patients With Gastric or GEJ Cancer, and Assessment of CTDNA as Correlative Biological Response

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Fluorouracil	2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15
DRUG	Leucovorin	200 mg mg/m2 IV over 2 hours Day 1,15
DRUG	Oxaliplatin	85 mg/m2 IV over 2 hours Day 1,15
DRUG	Docetaxel	60 mg/m2 IV over 60 minutes Day 1,15
BIOLOGICAL	GSCF	Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16

Timeline

• Start date: 2024-03-06
• Primary completion: 2025-02-20
• Completion: 2025-02-20
• First posted: 2022-10-05
• Last updated: 2026-04-09
• Results posted: 2026-02-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study