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Perioperative FLOT vs Adjuvant XELOX for CA Stomach

NCT05264896 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-09-07

No results posted yet for this study

Summary

This is a single centre randomised controlled trial, comparing perioperative FLOT versus adjuvant XELOX for locally advanced gastric and esophagogastric junction cancers. Patients with operable clinical T3 or above and N1 or above gastric and esophagastric junction cancer would be recruited. Participants would be randomised to perioperative FLOT versus adjuvant XELOX with curative radical gastrectomy. Primary outcome would be 3 year Disease Free Survival. It was calculated that 110 patients would be required to demonstrate the study hypothesis.

Conditions

  • Cancer of Stomach, Adenocarcinoma

Interventions

DRUG

5-FU, Leucovorin, Oxaliplatin, Docetaxel

FLOT 4 cycles pre and post radical gastrectomy

DRUG

XELOX

XELOX 8 cycles post radical gastrectomy

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Hon Chi Yip, FRCSEd · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2024-12-31
Completion
2027-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05264896 on ClinicalTrials.gov