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Perioperative Chemotherapy in Gastric Cancer (PECORINO)

Primary Purpose

Gastric Cancer

Status

Active

Phase

Phase 2

Locations

Ukraine

Study Type

Interventional

Intervention

Docetaxel

Oxaliplatin

Leucovorin

Fluorouracil

Capecitabine

Oxaliplatin

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring perioperative chemotherapy, pathological responce rate, gastrectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ukrainian Society of Clinical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

XELOX

FLOT

Arm Description

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

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

Outcomes

Primary Outcome Measures

Histopathological regression rate (Becker regression criteria)

To determine histopathological regression rate after FLOT regimen compared to XELOX regimen in neoadjuvant settings

Secondary Outcome Measures

Chemotherapy toxicity profile

To determine and compare toxicity profile in patients receiving XELOX or FLOT regimen

Surgical complications rate

To determine surgical complication rate and profile after different types of regimens in neoadjuvant settings

1-year disease-free survival rate

To determine the efficacy of FLOT regimen compared to XELOX regimen during the first year after the surgery

Correlation between histopathological regression and disease-free survival

To determine correlation between histopathological regression and disease-free survival in different chemotherapeutic settings

Median overall survival

To determine the efficacy of FLOT regimen compared to XELOX regimen by assessment of overall survival

Full Information

NCT ID

NCT04937738

First Posted

June 4, 2021

Last Updated

May 22, 2023

Sponsor

Ukrainian Society of Clinical Oncology

1. Study Identification

Unique Protocol Identification Number

NCT04937738

Brief Title

Perioperative Chemotherapy in Gastric Cancer

Acronym

PECORINO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 21, 2021 (Actual)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

July 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ukrainian Society of Clinical Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

perioperative chemotherapy, pathological responce rate, gastrectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

284 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

XELOX

Arm Type

Active Comparator

Arm Description

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

Arm Title

FLOT

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

50mg/m2, d1, i.v., every 2 weeks

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

85 mg/m², d1, i.v., every 2 weeks

Intervention Type

Drug

Intervention Name(s)

Leucovorin

Intervention Description

200 mg/m², d1, i.v., every 2 weeks

Intervention Type

Drug

Intervention Name(s)

Fluorouracil

Intervention Description

2600 mg/m²d1 i.v. every 2 weeks

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

1000 mg/m² two times per day (BID), d1-14

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

130 mg/m² d1 i.v. every 3 weeks

Primary Outcome Measure Information:

Title

Histopathological regression rate (Becker regression criteria)

Description

To determine histopathological regression rate after FLOT regimen compared to XELOX regimen in neoadjuvant settings

Time Frame

2 weeks after surgery

Secondary Outcome Measure Information:

Title

Chemotherapy toxicity profile

Description

To determine and compare toxicity profile in patients receiving XELOX or FLOT regimen

Time Frame

at the end of XELOX cycle (each cycle is 21 days) and FLOT cycle (each cycle is 14 days)

Title

Surgical complications rate

Description

To determine surgical complication rate and profile after different types of regimens in neoadjuvant settings

Time Frame

up to 90th day after surgery

Title

1-year disease-free survival rate

Description

To determine the efficacy of FLOT regimen compared to XELOX regimen during the first year after the surgery

Time Frame

1 year after surgery

Title

Correlation between histopathological regression and disease-free survival

Description

To determine correlation between histopathological regression and disease-free survival in different chemotherapeutic settings

Time Frame

2 years of follow-up after the last cycle of chemotherapy

Title

Median overall survival

Description

To determine the efficacy of FLOT regimen compared to XELOX regimen by assessment of overall survival

Time Frame

5 year follow up after the last cycle of chemotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Ukrainian Society of Clinical Oncology

City

Mykolaiv

ZIP/Postal Code

54001

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Perioperative Chemotherapy in Gastric Cancer

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