← Back to Search

Chemotherapy

Chemotherapy Decision Test for Gastroesophageal Cancer

Phase 1

Waitlist Available

Led By Farshid Dayyani, MD,PhD

Research Sponsored by University of California, Irvine

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 up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new test to decide if chemo is needed for stomach or GEA cancer.

Who is the study for?

This trial is for adults with Stage IB, II or III gastroesophageal adenocarcinoma who can consent to treatment. They must have a positive ctDNA blood test and be fit enough for chemotherapy (ECOG ≤2). Pregnant women, those with other active cancers, uncontrolled illnesses, or known metastases from GEA are excluded.

What is being tested?

The RANT-GC Trial tests if using ctDNA results to guide neoadjuvant chemotherapy improves outcomes in stomach or gastroesophageal junction cancer. It includes various chemo regimens like FOLFIRINOX and NIVOLUMAB, alone or combined.

What are the potential side effects?

Chemotherapy drugs used may cause side effects such as nausea, fatigue, hair loss, increased risk of infection due to low blood counts, nerve damage leading to numbness or tingling sensations and allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of completing per protocol treatment.

Secondary study objectives

Percentage of Grade 3-5 Adverse Events

Percentage of patients completing gastrectomy.

Rate of R0 resection

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant chemotherapy with ctDNA testingExperimental Treatment9 Interventions

The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If no decline in ctDNA detected after 4 cycles, treatment will be switched to a different chemotherapy backbone (e.g. irinotecan based regimen, or taxane based if not used upfront). ctDNA will be re-evaluated after 3 cycles (if a 21 day regimen) or 4 cycles (if a 14 day regimen) of the 2nd line regimen. If ctDNA is lower than the previous measurement, then the same regimen continues for 3-4 more cycles (depending on 14 day or 21 day cycle), followed by gastrectomy. Adjuvant treatment is given based on the investigator's discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FOLFIRINOX

2013

Completed Phase 3

~800

FLOT

2018

Completed Phase 2

~270