RECRUITING

Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.

Official Title

Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)

Quick Facts

Study Start:2023-10-05
Study Completion:2031-01-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06101290

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:
  2. 1. Cohort A: prostate cancer
  3. 2. Cohort B: urothelial carcinoma
  4. 3. Cohort C: renal cell carcinoma
  5. 2. Provision of signed and dated informed consent form.
  6. 3. Stated willingness to comply with all study procedures and availability for the duration of the study.
  7. 4. Age ≥18 years at time of consent.
  8. 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.
  9. 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. \[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\]
  10. 7. ≤ 5 progressing or new metastatic lesions.
  11. 8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.
  1. 1. Medical comorbidities precluding locally ablative therapies.
  2. 2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
  3. 3. Progressing intracranial lesions.

Contacts and Locations

Study Contact

Selina Laqui
CONTACT
916-734-0565
sblaqui@ucdavis.edu

Principal Investigator

Mamta Parikh, MD, MS
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

University of California, Davis
Sacramento, California, 95817
United States

Collaborators and Investigators

Sponsor: University of California, Davis

  • Mamta Parikh, MD, MS, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-05
Study Completion Date2031-01-05

Study Record Updates

Study Start Date2023-10-05
Study Completion Date2031-01-05

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Oligoprogressive
  • Urothelial Carcinoma
  • Renal Cell Carcinoma