Perioperative Chemotherapy in Gastric Cancer (PECORINO)

November 5, 2024 updated by: Oleksii Dobrzhanskiy, Ukrainian Society of Clinical Oncology

Treatment Discontinuation Associated With Perioperative Toxicity of FLOT Versus XELOX Chemotherapy in Patient With Resectable Gastric Cancer; Phase 2

Patients with resectable adenocarcinoma of stomach or esophagogastric junction without previous therapy will be treated with one of two chemotherapy regimens perioperatively. One group of the patients will receive 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the second group will receive Oxaliplatin and Capecitabin (XELOX). Primary endpoint of the study is the proportion of patients who complete all allocated treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

328 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 staging laparocopy patients will be randomized to receive preoperatively 4 cycles FLOT or 4 cycles XELOX followed by curative surgery. Adjuvant chemotherapy will be given as 4 cycles of FLOT or 4 cycles XELOX. The primary endpoint is the proportion of patients who fully adhered to all the allocated treatment per protocol. Secondary endpoints are pathological regression grade, progression free survival, overall survival, chemotherapy and surgery complications rates.

Study Type

Interventional

Enrollment (Actual)

69

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
      • Kyiv, Ukraine, 03022
        • National Cancer Institute

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: Perioperative XELOX chemotherapy
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
Other Names:
  • oxaliplatine
Experimental: Perioperative FLOT chemotherapy
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
Other Names:
  • oxaliplatine
Drug: Fluorouracil
2600 mg/m²d1 i.v. every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who complete all the treatment per protocol
Time Frame: Up to 2 months
Completed treatment protocol is considered as 4 cycles neoadjuvant chemotherapy followed by curative surgery and 4 cycles of adjuvant chemotherapy.
Up to 2 months

Secondary 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
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

Investigators

  • Principal Investigator: Oleksii Dobrzhanskyi, MD, National Cancer Institute (NCI)

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 (Actual)

February 1, 2023

Study Completion (Actual)

February 1, 2023

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)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2024

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 Access Criteria

By request

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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