HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT)

Sponsor
Krankenhaus Nordwest
Study ID
NCT04447352
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 5-Fluorouracil — DRUG
    Day 1 q2w: 2600 mg/m² IV over 24 hours
  • Leucovorin — DRUG
    Day 1 q2w: 200 mg/m² IV over 30 minutes
  • Oxaliplatin — DRUG
    Day 1 q2w: 85 mg/m² IV over 2 hours
  • Docetaxel — DRUG
    Day 1 q2w: 50 mg/m² IV over 1 hour
  • Cisplatin — DRUG
    intraoperative: 75mg/m² intraabdominal solution over 1 hour and 30 minutes

Study Details

This is a multicenter, randomized, controlled, open-label study evaluating efficacy and safety of perioperative FLOT chemotherapy plus intraoperative HIPEC versus FLOT chemotherapy alone in patients with resectable localized and locally advanced diffuse and mixed type adenocarcinoma of the stomach and Type II/III GEJ.

Key Dates

First listed
Jun 25, 2020
Start date
Dec 17, 2020
Status verified
Nov 2024
Primary completion
Nov 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A - FLOT
    Patients randomized to treatment Arm A already received 3-6 cycles of FLOT in 2-week treatment cycles prior to undergoing surgery. Following surgery, patients will receive four further 2-week cycles FLOT. FLOT can be deescalated to FLO, FLT or FL in case of chemorelated toxicity at any time and at the discretion of investigator. FLOT = Docetaxel 50 mg/m², Oxaliplatin 85 mg/m², Leucovorin 200 mg/m², 5-FU 2600 mg/m².
  • Experimental: Arm B - FLOT/HIPEC
    Patients randomized to treatment Arm B already received 3-6 cycles of FLOT in 2-week treatment cycles prior to undergoing surgery including Intraoperative Hyperthermic IntraPEritoneal Chemoperfusion (HIPEC) during gastric-/ esophagogastric resection using Cisplatin 75mg/m². Following surgery, patients will receive four further 2-week cycles FLOT. FLOT can be deescalated to FLO, FLT or FL in case of chemorelated toxicity at any time and at the discretion of investigator. FLOT = Docetaxel 50 mg/m², Oxaliplatin 85 mg/m², Leucovorin 200 mg/m², 5-FU 2600 mg/m².

Primary Outcome Measure

Comparison of progression-/disease-free survival (PFS/DFS) between arms [ Time Frame: from randomization up to 5 years ]

Central Contacts

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