NCT03606928

mFLOT Chemotherapy as First-line Treatment in GC

Modified FLOT Chemotherapy as First-line Treatment in Advanced or Metastatic Gastric Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A single center phase 1b/2 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.

Detailed description

The RP2D of FLOT regime will be established with a standard 3+3 design, starting with the dose of 40mg/m2 docetaxel (dose level 1) and 65mg/m2 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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	docetaxel, oxaliplatin, 5-FU, leucovorin	This is a single-arm study with all patients receiving mFLOT chemotherapy.

Timeline

• Start date: 2018-07-01
• Primary completion: 2019-11-09
• Completion: 2020-01-01
• First posted: 2018-07-31
• Last updated: 2020-03-20

Locations

1 site across 1 country: China