Perioperative Chemotherapy in Gastric Cancer (PECORINO)

May 22, 2023 updated by: Ukrainian Society of Clinical Oncology

Evaluation of Pathological Response in Patient With Resectable Gastric Cancer and Perioperative Chemotherapy FLOT Versus XELOX; Phase 2

Patients with resectable adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be treated with one of two chemotherapy combinations before and after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others Oxaliplatin and Capecitabin (XELOX). Main objective of the study is histopathological regression rate.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

284 рatients with resectable (T1b-4 and/or N-/+, M0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After laparocopic staging patients will be randomized to receive preoperatively 4 cycles FLOT or 4 cycles XELOX followed by surgery. Subsequently another 4 cycles of FLOT or 4 cycles XELOX are applicated. Primary endpoint is histopathological regression rate, secondary endpoints are disease-free survival, perioperative morbidity and mortality, correlation between pathological responce and disease-free survival.

Study Type

Interventional

Enrollment (Anticipated)

284

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Mykolaiv, Ukraine, 54001
        • Ukrainian Society of Clinical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • cT1b-T4b (cT4b - invasion in diaphragm, parenchyma of liver, spleen, pancreas, abdominal wall, small bowel, colon, distal part of splenic artery)
  • cN0-3
  • M0
  • Age: 18 - 80
  • ECOG: 0 - 1
  • Histological type: adenocarcinoma
  • Differentiation grade: G0 - G4
  • No previous surgery
  • No previous chemotherapy
  • No concomitant severe comorbidity
  • Written informed consent

Exclusion Criteria:

  • cT1a, cT4b (invasion in truncus, hepatic artery, proximal part of splenic artery)
  • Presense of distant metastases
  • ECOG: 2 - 5
  • Age: <18 and >80
  • Severe concomitant comorbidity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: XELOX
Oxaliplatin 130 mg/m2, d1 Capecitabine 1000 mg/m² two times per day (BID), d1-14, every 3 weeks (q3w) 4 cycles (12 weeks) pre-OP and 3 cycles (12 weeks) post-OP
Drug: Oxaliplatin
85 mg/m², d1, i.v., every 2 weeks
Drug: Capecitabine
1000 mg/m² two times per day (BID), d1-14
Drug: Oxaliplatin
130 mg/m² d1 i.v. every 3 weeks
Experimental: FLOT
Docetaxel 50mg/m2, d1 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (8 weeks) pre-OP and 4 cycles (8 weeks) post-OP
Drug: Leucovorin
200 mg/m², d1, i.v., every 2 weeks
Drug: Oxaliplatin
85 mg/m², d1, i.v., every 2 weeks
Drug: Docetaxel
50mg/m2, d1, i.v., every 2 weeks
Drug: Oxaliplatin
130 mg/m² d1 i.v. every 3 weeks
Drug: Fluorouracil
2600 mg/m²d1 i.v. every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histopathological regression rate (Becker regression criteria)
Time Frame: 2 weeks after surgery
To determine histopathological regression rate after FLOT regimen compared to XELOX regimen in neoadjuvant settings
2 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemotherapy toxicity profile
Time Frame: at the end of XELOX cycle (each cycle is 21 days) and FLOT cycle (each cycle is 14 days)
To determine and compare toxicity profile in patients receiving XELOX or FLOT regimen
at the end of XELOX cycle (each cycle is 21 days) and FLOT cycle (each cycle is 14 days)
Surgical complications rate
Time Frame: up to 90th day after surgery
To determine surgical complication rate and profile after different types of regimens in neoadjuvant settings
up to 90th day after surgery
1-year disease-free survival rate
Time Frame: 1 year after surgery
To determine the efficacy of FLOT regimen compared to XELOX regimen during the first year after the surgery
1 year after surgery
Correlation between histopathological regression and disease-free survival
Time Frame: 2 years of follow-up after the last cycle of chemotherapy
To determine correlation between histopathological regression and disease-free survival in different chemotherapeutic settings
2 years of follow-up after the last cycle of chemotherapy
Median overall survival
Time Frame: 5 year follow up after the last cycle of chemotherapy
To determine the efficacy of FLOT regimen compared to XELOX regimen by assessment of overall survival
5 year follow up after the last cycle of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ukrainian Society of Clinical Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2021

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2029

Study Registration Dates

First Submitted

June 4, 2021

First Submitted That Met QC Criteria

June 23, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After the initial publication every participant will recieve all the data to provide further data exploration.

IPD Sharing Time Frame

Data will be available after initial paper is published.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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