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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07282912
Phase
PHASE2
Status
Recruiting
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Conditions

  • Ampullary Adenocarcinoma
  • Duodenal Adenocarcinoma
  • Esophageal Adenocarcinoma
  • Foregut Adenocarcinoma
  • Gallbladder Adenocarcinoma
  • Gastric Adenocarcinoma
  • Gastroesophageal Adenocarcinoma
  • Intra - and Extrahepatic Cholangiocarcinoma
  • Pancreas Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Sequential cytoreductive intervention — PROCEDURE
    A treatment plan that involves multiple procedures given one after another to remove cancerous tumors depending on metastasis.
  • Signatera Genome ultra-sensitive ctDNA blood test — DIAGNOSTIC_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.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sequential cytoreductive intervention
    Following the determination of undetectable levels of ctDNA, patients will undergo cytoreductive interventions for a total of three months. All sequential cytoreductive interventions must be completed within the three-month time frame following randomization. ctDNA levels will be measured.
  • Active Comparator: Standard of care
    Following the determination of undetectable levels of ctDNA, patients will continue the standard of care therapy until progression.

Primary Outcome Measure

Number of participants with Progression Free Survival (PFS) [ Time Frame: up to 12 months post-randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Smilow Cancer CenterNew HavenConnecticut06519-

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By research site
Smilow Cancer Center· New Haven, CT

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