← Back to Search

Taxane

Chemotherapy for Stomach Cancer (TOGAR Trial)

Phase 2
Recruiting
Led By Tannaz Armaghany, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 16 for arm a and at week 24 for arm b
Awards & highlights

TOGAR Trial Summary

This trial will compare two types of chemotherapy to see which is more effective.

Who is the study for?
Adults with confirmed gastric or gastroesophageal junction adenocarcinoma, who are fit for chemotherapy and surgery aimed at curing the cancer. They must have good organ function, no distant metastases, and be able to follow trial procedures. Women of childbearing age need a negative pregnancy test and agree to use contraception.Check my eligibility
What is being tested?
The study is testing two approaches using FLOT chemotherapy: one where all treatment is given before surgery (Total Neoadjuvant - FLOT-TNT) versus the standard method where it's given before and after surgery (Perioperative - FLOT-POP). The goal is to see which approach has better completion rates.See study design
What are the potential side effects?
Possible side effects include reactions to the drugs like nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling in hands/feet, hair loss from Docetaxel, and mouth sores.

TOGAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 16 for arm a and at week 24 for arm b
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 16 for arm a and at week 24 for arm b for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Completion rate of Participants who have completed their all-allocated treatments, either Arm A: FLOT-TNT or Arm B: FLOT-POP
Secondary outcome measures
Number of positive lymph nodes
Pathologic response rate

TOGAR Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: FLOT-POP ( Standard Arm)Experimental Treatment5 Interventions
Arm B us the standard perioperative arm with 2 cycles of pre-operative FLOT ( 4 treatment sessions) and 2 cycles ( 4 treatment sessions) of post-operative FLOT. Post-surgery FLOT will start 4-6 weeks post surgery. Each cycle of chemotherapy consists of 28 days and consists of 2 chemotherapy sessions given every 14 days. The total number of chemotherapy sessions in arm B is 8. Every effort should be done to have surgery done in week 12 ( -1 to +2 weeks) post completion of cycle 2 on ARM B.
Group II: Arm A: FLOT-TNT ( Investigational Arm)Experimental Treatment5 Interventions
Arm A is the investigational arm with all 4 cycles of FLOT given as total neoadjuvant chemotherapy prior to surgery. Each cycle is 28 days and consists of 2 chemotherapy sessions given every 14 days. The total number of chemotherapy sessions in Arm A is 8. Every effort will be made to have surgery in week 20 ( -1 to +2 weeks), 4 weeks post C4 on arm A.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
2005
Completed Phase 4
~5730
Oxaliplatin
2011
Completed Phase 4
~2560
Docetaxel
1995
Completed Phase 4
~5620
Fluorouracil
2014
Completed Phase 3
~11540

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,362 Total Patients Enrolled
Tannaz Armaghany, MDPrincipal InvestigatorBaylor College of Medicine
3 Previous Clinical Trials
46 Total Patients Enrolled

Media Library

Docetaxel (Taxane) Clinical Trial Eligibility Overview. Trial Name: NCT05567835 — Phase 2
Docetaxel (Taxane) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05567835 — Phase 2
Stomach Cancer Research Study Groups: Arm A: FLOT-TNT ( Investigational Arm), Arm B: FLOT-POP ( Standard Arm)
Stomach Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT05567835 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks have been found to be associated with the FLOT-POP regimen?

"Due to the limited efficacy data from Phase 2, Arm B: FLOT-POP (Standard Arm) has been rated a two for safety by Power."

Answered by AI

Is there availability for individuals to participate in this experiment?

"As noted on clinicaltrials.gov, this specific trial is no longer enrolling participants. This medical experiment was first published in the beginning of January 2023 and last updated at the end of November 2022; however, there are still 787 other active studies that can be accessed."

Answered by AI

Who else is applying?

What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients With Gastric or GEJ Cancer
Tannaz Armaghnay 2024. "A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients With Gastric or GEJ Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05567835.
~33 spots leftby Oct 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top