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

Clinicaltrials.gov ID: NCT06101290
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 150

Conditions

Prostate Cancer, Oligoprogressive, Urothelial Carcinoma, Renal Cell Carcinoma

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 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.

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 as the primary objective. The primary endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. Participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. Participants will be assigned stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy per the discretion of treating radiation oncologist and/or interventional radiologist.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Mamta Parikh, MD, MS

Eligibility Criteria

Inclusion Criteria:

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

1. Cohort A: prostate cancer
2. Cohort B: urothelial carcinoma
3. Cohort C: renal cell carcinoma
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.

Study Plan

Ablative local therapy

EXPERIMENTAL

Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy

  • DEVICE:

    Ablative local therapy

    Description:

    Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy

Outcome Measures

Primary Outcome Measures

Number of participants with controlled disease

Time Frame: 3 months from the first day of ablative local therapy

Secondary Outcome Measures

Number of participants experiencing grade u2265 3 adverse events attributable to ablative local therapy

Time Frame: Up to 2 years from the first day of ablative local therapy

Median overall survival

Time Frame: Up to 1 year from the first day of ablative local therapy

Time to treatment failure

Time Frame: Up to 1 year from the first day of ablative local therapy

Timeline

  • Last Updated
    December 4, 2023
  • Start Date
    October 26, 2023
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    January 5, 2031

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