Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels

This is a randomized, open label, single-center, phase 2, randomized controlled trial of sequential cytoreductive intervention versus standard of care therapy for patients with intervenable oligometastatic (stage IV) cancer of the upper gastrointestinal (GI) tract and undetectable ctDNA at the time of randomization after a three-month induction chemotherapy period.

Trial Details

NCT ID

NCT07282912

Phase

PHASE2

Sponsor

Yale University

Status

RECRUITING

Cancer Type

Adenocarcinoma Esophageal Cancer

Interventions

Sequential cytoreductive intervention
Signatera Genome ultra-sensitive ctDNA blood test

Locations (sample)

New Haven, Connecticut, United States|41.30815,-72.92816

Key Eligibility Criteria

Has a primary diagnosis of AJCC 8th Edition Stage IV esophageal or gastroesophageal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcino…
a) All participants must have confirmed histologic diagnosis of the primary tumor, which may be confirmed retrospectively by a radiologist if neces…
Has a primary tumor that must be locally resectable or can be treated definitively. Primary tumors included are esophageal, gastric, duodenal, ampu…
Has limited (2 sites) metastatic disease determined to be completely resectable or treatable with curative intention (see SOE) at the time of diagn…

For full eligibility, visit ClinicalTrials.gov.

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