Actively Recruiting
Locally Ablative Therapy for Oligoprogressive Lung and Thoracic Malignancies (OBLITERATE)
Led by University of California, Davis · Updated on 2023-10-31
100
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical benefit of adding locally ablative therapies to ongoing systemic treatment for patients with oligo-progressive solid tumors, specifically non-small cell lung cancer and small cell lung cancer. This phase 2 pragmatic study aims to measure how well disease control is maintained, focusing on the time to treatment failure and continuation of systemic therapy without changes or discontinuation after local therapy. The study is conducted at a single site and sponsored by the University of California, Davis. Participants will receive locally ablative therapy, which includes stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation, in addition to their current systemic therapy. The choice of local therapy is determined by the treating radiation oncologist or interventional radiologist. The study follows participants for up to five years after the first day of ablative therapy to monitor outcomes and adverse events. During the study, participants will be assessed for disease control at three months, defined by continuation of systemic cancer therapy without change or discontinuation. Researchers will also monitor for adverse events related to local therapy, overall survival, and time to treatment failure for up to one to two years. Participants will undergo regular follow-up visits and evaluations to track their treatment response and safety throughout the study duration.
CONDITIONS
Brief Title
LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs (OBLITERATE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have confirmed non-small cell or small cell lung cancer
- Age 18 years or older at time of consent
- Currently receiving systemic therapy and able to continue with no more than a 30-day break for local therapy
- At least one line of systemic therapy for metastatic disease with at least 3 months of clinical benefit before new metastatic lesions
- Five or fewer progressing or new metastatic lesions
- All progressing or new lesions must be safely treatable with local ablative therapies
- Willingness to comply with study procedures and availability for study duration
- Signed informed consent form
You will not qualify if you...
- Medical conditions preventing use of locally ablative therapies
- History of treatment-related toxicities limiting local ablative therapy
- Progressing brain (intracranial) lesions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 3 months from the first day of ablative local therapy
Participants receive ablative local therapy, which includes stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy, in addition to continuing systemic therapy.
Visits as needed for ablative local therapy and systemic therapy management
Duration - Up to 2 years following ablative local therapy
Participants are followed for safety monitoring and assessment of overall survival and treatment failure after completing ablative local therapy.
Regular follow-up visits during the 2-year period
Trial Site Locations
Total: 1 location
1
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
S
Selina Laqui
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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