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

NCT ID: NCT06101290

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-05

Study Completion Date

2031-01-05

Brief Summary

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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

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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.

Conditions

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Prostate Cancer Oligoprogressive Urothelial Carcinoma Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ablative local therapy

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

Group Type EXPERIMENTAL

Ablative local therapy

Intervention Type DEVICE

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

Interventions

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Ablative local therapy

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Responsible Party

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Mamta Parikh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mamta Parikh, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California, Davis

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Selina Laqui

Role: CONTACT

Phone: 916-734-0565

Email: [email protected]

Facility Contacts

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Selina Laqui

Role: primary

Other Identifiers

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UCDCC312

Identifier Type: -

Identifier Source: org_study_id