NCT04597294

Brief Summary

The study was designed to evaluate the efficacy of perioperative FLOT chemotherapy in combination with perioperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced gastric cancer at high risk of peritoneal metastases. The impact of treatment on peritoneal recurrence and survival over 6 months, 1, 3 and 5 years will be assessed.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P50-P75 for phase_3 gastric-cancer

Timeline
4mo left

Started Aug 2021

Typical duration for phase_3 gastric-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Aug 2021Dec 2026

First Submitted

Initial submission to the registry

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

4.4 years

First QC Date

October 15, 2020

Last Update Submit

March 4, 2024

Conditions

Gastric Cancer

Keywords

HIPECFLOTGastric cancerLymphadenectomy

Outcome Measures

Primary Outcomes (1)

  • Peritoneal recurrence rate

    The rate of peritoneal recurrences at 6 month time from randomisation

    6 months

Secondary Outcomes (10)

  • Overall survival

    6 months

  • Overall survival

    3 years

  • Overall survival

    5 years

  • Local recurrence rate

    3 years

  • Systemic recurrence rate

    3 years

  • +5 more secondary outcomes

Study Arms (2)

Perioperative FLOT + prophylactic HIPEC + surgery

EXPERIMENTAL

After 4 doses of preoperative FLOT chemotherapy diagnostic laparoscopy will be performed - patients without distant metastases will be randomised, in those randomised to experimental arm HIPEC with irinotecan will be performed (a dose of 300 mg/m2 body surface area will be administered over 45 minutes at a temperature of 42 degrees Celsius)

Combination Product: FLOT + HIPEC + Surgery

Perioperative FLOT + surgery

ACTIVE COMPARATOR

Standard treatment regimen for advanced gastric cancer

Combination Product: FLOT + Surgery

Interventions

FLOT + HIPEC + SurgeryCOMBINATION_PRODUCT

HIPEC with irinotecan after 4 doses of preoperative FLOT chemotherapy

Also known as: Prophylactic HIPEC
Perioperative FLOT + prophylactic HIPEC + surgery
FLOT + SurgeryCOMBINATION_PRODUCT

Perioperative FLOT chemotherapy (4 doses before and 4 doses after gastrectomy) and surgery

Also known as: Perioperative FLOT + Surgery
Perioperative FLOT + surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gastric cancer confirmed histopathologically in tumor specimens.
  • Age 18-75 years.
  • Advanced gastric cancer cT3 / cT4a / N0-3b.
  • No distant metastases on computed tomography (CT) scan of the chest, abdomen and pelvis (cM0).
  • Written consent to participate in the study.

You may not qualify if:

  • No clear histopathological confirmation of gastric cancer.
  • Age \> 75 years.
  • Poor general condition (Performance Status 3 or more on the Eastern Cooperative Oncology Group (ECOG)/World Health Organization scale).
  • Previous abdominal surgery (including oncological surgery), other than laparoscopic cholecystectomy or appendectomy (open or laparoscopic).
  • Pregnancy and lactation.
  • Refusal to participate or an inability to provide written consent.
  • Coexisting cancer in another location.
  • Systemic treatment or radiotherapy for another cancer.
  • Dysphagia requiring surgical treatment (gastric resection or nutritional jejunostomy) before starting neoadjuvant treatment and indication for accelerated surgery for other reasons.
  • Disqualification for perioperative FLOT4 chemotherapy as decided by a multi-specialist consultation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General, Oncological, Gastroenterological Surgery and Transplantology

Krakow, Lesser Poland Voivodship, 30-688, Poland

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Hyperthermic Intraperitoneal ChemotherapySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, Induced

Study Officials

  • Piotr Richter, Professor

    Jagiellonian University

    STUDY DIRECTOR

Central Study Contacts

Piotr Richter, Professor

CONTACT

+48124002400piotr.richter@uj.edu.pl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomization 1:1
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

August 1, 2021

Primary Completion

January 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)