LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs (OBLITERATE)
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.
Conditions:
🦠 Non-small Cell Lung Cancer 🦠 Oligoprogressive 🦠 Small-cell Lung Cancer
🗓️ Study Start (Actual) 5 October 2023
🗓️ Primary Completion (Estimated) 5 December 2025
✅ Study Completion (Estimated) 5 January 2031
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Sacramento, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:
    • 1. Cohort A: Non-small cell cancer
    • 2. Cohort B: Small cell cancer
    • 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 19 October 2023
  • First Submitted that Met QC Criteria 19 October 2023
  • First Posted 27 October 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 October 2023
  • Last Update Posted 31 October 2023
  • Last Verified October 2023