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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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 16 for arm a and at week 24 for arm b

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Completion rate of Participants who have completed their all-allocated treatments, either Arm A: FLOT-TNT or Arm B: FLOT-POP

Secondary study objectives

Number of positive lymph nodes

Pathologic response rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6010

Oxaliplatin

2011

Completed Phase 4

~2890