Combining local therapy with ongoing systemic treatment for certain cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 pragmatic study evaluates the benefits of continuing systemic therapy while adding locally ablative therapies for patients with oligo-progressive solid tumors. The primary goal is to measure disease control at 3 months, defined as the ability to continue systemic therapy without changes or permanent discontinuation after receiving local ablative therapy. Participants will receive either stereotactic ablative radiotherapy or interventional radiology ablation therapy, depending on the discretion of their treating specialists. The study will follow participants for up to 5 years to assess long-term outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Must have one of the following histologically and/or biochemically confirmed cancers:

   1. Cohort A: (Cohort removed in protocol version 4.0)
   2. Cohort B: Small bowel
   3. Cohort C: Pancreatic and ampullary, colorectal, and appendiceal
   4. Cohort D: (Cohort removed in protocol version 4.0)
2. Provision of signed and dated informed consent form.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.
4. Age ≥18 years at time of consent.
5. 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.
6. ≥ 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. \[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\]
7. ≤ 5 progressing or new metastatic lesions.
8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.

Exclusion Criteria:

1. Medical comorbidities precluding locally ablative therapies.
2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
3. Progressing intracranial lesions.

Where it's running

• University of California, Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting

Study contacts

• Principal investigator: Edward Kim, MD, PhD — University of California, Davis
• Study coordinator: Office of Clinical Research
• Email: OCRReferral@health.ucdavis.edu
• Phone: 916-382-6970

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.