PECORINO: Perioperative Chemotherapy in Gastric Cancer

Sponsor
Ukrainian Society of Clinical Oncology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04937738
Collaborator
(none)
284
1
2
95.3
3

Study Details

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
284 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Pathological Response in Patient With Resectable Gastric Cancer and Perioperative Chemotherapy FLOT Versus XELOX; Phase 2
Actual Study Start Date :
Jul 21, 2021
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2029

Arms and Interventions

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

Drug: Oxaliplatin
85 mg/m², d1, i.v., every 2 weeks

Drug: Leucovorin
200 mg/m², d1, i.v., every 2 weeks

Drug: Fluorouracil
2600 mg/m²d1 i.v. every 2 weeks

Outcome Measures

Primary Outcome Measures

  1. Histopathological regression rate (Becker regression criteria) [2 weeks after surgery]

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

Secondary Outcome Measures

  1. Chemotherapy toxicity profile [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

  2. Surgical complications rate [up to 90th day after surgery]

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

  3. 1-year disease-free survival rate [1 year after surgery]

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

  4. Correlation between histopathological regression and disease-free survival [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

  5. Median overall survival [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ukrainian Society of Clinical Oncology Mykolaiv Ukraine 54001

Sponsors and Collaborators

  • Ukrainian Society of Clinical Oncology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ukrainian Society of Clinical Oncology
ClinicalTrials.gov Identifier:
NCT04937738
Other Study ID Numbers:
  • 275
First Posted:
Jun 24, 2021
Last Update Posted:
Apr 12, 2022
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by Ukrainian Society of Clinical Oncology
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022