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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of completing per protocol treatment.
Secondary outcome measures
Percentage of Grade 3-5 Adverse Events
Percentage of patients completing gastrectomy.
Rate of R0 resection
+4 moreTrial 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
~790
FOLFOX
2009
Completed Phase 3
~4560
FOLFIRI
2005
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
542 Previous Clinical Trials
1,921,981 Total Patients Enrolled
Natera, Inc.Industry Sponsor
47 Previous Clinical Trials
42,347 Total Patients Enrolled
Farshid Dayyani, MD,PhDPrincipal InvestigatorChao Family Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.My cancer is confirmed to be in the stomach or where my stomach meets my esophagus.My stomach or esophagus cancer is at an early but operable stage.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My cancer was detected in a blood test before starting chemotherapy.My cancer has spread from my stomach or esophagus.My blood counts and liver/kidney functions are within normal ranges.I do not have another cancer needing treatment within a year.I agree to use birth control during and for 3 months after the study.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant chemotherapy with ctDNA testing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any grave risks associated with Neoadjuvant chemotherapy combined with ctDNA testing?
"Our Power team rated the safety of Neoadjuvant chemotherapy with ctDNA testing a 1, due to only minimal evidence for both efficacy and safety."
Answered by AI
Are there any open slots for enrolment in this clinical trial?
"Per clinicaltrials.gov, this particular medical trial is no longer recruiting patients to participate. The study was initially posted on February 1st 2023 and last updated 8 days later. Despite the lapse in recruitment, 774 other studies are currently looking for suitable candidates at this very moment."
Answered by AI
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