Chemotherapy Decision Test for Gastroesophageal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byFarshid Dayyani

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of California, Irvine

Stay on Your Current Meds

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a phase 1b prospective, single arm, open-label trial determining the efficacy and feasibility of using a ctDNA assay (test) result to help guide neoadjuvant chemotherapy in subjects with Stage IB, II or Stage III adenocarcinoma of the stomach or gastroesophageal junction (GEA).

Research Team

Farshid Dayyani

Principal Investigator

Chao Family Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion 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.

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Exclusion Criteria

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Patients may not be receiving any other investigational agents

History of allergic reactions attributed to agents used in study

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Treatment Details

Interventions

ctDNA Blood Test (Device)
Docetaxel (Chemotherapy)
FLOT (Chemotherapy)
FOLFIRI (Chemotherapy)
FOLFIRINOX (Chemotherapy)
FOLFOX (Chemotherapy)
Irinotecan (Chemotherapy)
Nivolumab (Monoclonal Antibodies)
Paclitaxel (Chemotherapy)
Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.

Docetaxel is already approved in Canada, Japan for the following indications: