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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

NCT07282912 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-03-04

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Sequential cytoreductive intervention

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

DIAGNOSTIC_TEST

Signatera 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.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Kiran Turaga, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07282912 on ClinicalTrials.gov