Status:
RECRUITING
Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Small Bowel Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary o...
Detailed Description
This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors...
Eligibility Criteria
Inclusion
- Must have one of the following histologically and/or biochemically confirmed cancers:
- Cohort A: Esophageal, Gastroesophageal Junction, Gastric
- Cohort B: Small bowel
- Cohort C: Colorectal and appendiceal
- Cohort D: Biliary including gallbladder, intrahepatic and extrahepatic cholangiocarcinoma
- Cohort E: Hepatocellular carcinoma
- Cohort F: Pancreatic and ampullary
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age ≥18 years at time of consent.
- Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.
- ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\]
- ≤ 5 progressing or new metastatic lesions.
- All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.
Exclusion
- Medical comorbidities precluding locally ablative therapies.
- History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
- Progressing intracranial lesions.
Key Trial Info
Start Date :
October 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 5 2031
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06101277
Start Date
October 5 2023
End Date
January 5 2031
Last Update
January 6 2025
Active Locations (1)
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1
University of California, Davis
Sacramento, California, United States, 95817