RecruitingPhase 3NCT05264896

Perioperative FLOT vs Adjuvant XELOX for CA Stomach

Perioperative FLOT Versus Adjuvant XELOX for Locally Advanced Gastric Cancer - a Randomized Controlled Study


Sponsor

Chinese University of Hong Kong

Enrollment

110 participants

Start Date

Mar 21, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy strategies for people with locally advanced stomach or gastroesophageal junction (GEJ) cancer. One approach (FLOT) gives chemotherapy before and after surgery; the other (XELOX) gives chemotherapy only after surgery. The goal is to find out which approach works better. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with locally advanced adenocarcinoma of the stomach or where the esophagus meets the stomach - Your cancer is Stage T3 or higher and/or has spread to nearby lymph nodes, but has not spread to distant organs - Your cancer is considered surgically removable - You have not had prior stomach surgery or chemotherapy - You are in generally good health (ECOG 0–2) **You may NOT be eligible if...** - Your cancer has spread to other organs (distant metastases) - You have an allergy to any of the study drugs - You have serious heart disease (NYHA Class III or IV heart failure) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG5-FU, Leucovorin, Oxaliplatin, Docetaxel

FLOT 4 cycles pre and post radical gastrectomy

DRUGXELOX

XELOX 8 cycles post radical gastrectomy


Locations(1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

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NCT05264896


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