RecruitingPhase 2NCT07282912

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

Phase II Prospective, Open Label Randomized Controlled 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


Sponsor

Yale University

Enrollment

54 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether surgically removing or ablating the primary tumor — after it responds well to standard chemotherapy and when a blood marker called ctDNA becomes undetectable — improves survival in patients with metastatic cancers of the digestive tract (stomach, pancreas, bile ducts, gallbladder, and others). **You may be eligible if...** - You have been diagnosed with Stage IV adenocarcinoma of the esophagus, stomach, pancreas, bile ducts, gallbladder, duodenum, or ampulla - Your primary tumor is considered surgically removable or treatable with radiation/ablation - Your ctDNA level (cancer DNA found in blood) has become undetectable after initial chemotherapy - Your cancer has been confirmed by biopsy **You may NOT be eligible if...** - Your ctDNA is still detectable after chemotherapy - Your primary tumor cannot be removed or treated with a local procedure - You do not meet organ function or performance requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESequential cytoreductive intervention

A treatment plan that involves multiple procedures given one after another to remove cancerous tumors depending on metastasis.

DIAGNOSTIC_TESTSignatera Genome ultra-sensitive ctDNA blood test

A personalized blood test that detects circulating tumor DNA (ctDNA) to monitor for molecular residual disease (MRD) in patients who have been diagnosed with cancer.


Locations(1)

Smilow Cancer Center

New Haven, Connecticut, United States

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NCT07282912


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