Status:
RECRUITING
Total RadIoTherapy of Oligometastatic caNcerS
Lead Sponsor:
University of California, San Diego
Conditions:
Oligometastatic Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase III non-blinded randomized study evaluating patients with oligometastatic cancers (up to 10 metastases). Subjects are randomized 1:1 to stereotactic ablative radiotherapy (SABR) plus s...
Detailed Description
Patients with metastatic solid malignancies are generally deemed incurable. Systemic therapies (cytotoxic chemotherapy, immunotherapy, hormonal therapy, etc.) can be effective for prolonging life, but...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age at least 18 years.
- Deemed eligible to undergo standard systemic therapy and SABR to metastatic sites (i.e., patient has adequate health and life expectancy, and treatment is not contraindicated).
- Histopathologic confirmation of a solid malignancy.
- Newly diagnosed or progressive metastasis (at least 1 and no more than 10 discrete distant metastases visible on staging imaging. At least one metastatic lesion must be outside the brain parenchyma) for which a new line of systemic therapy is started or resumed.
- New systemic therapy for metastatic disease initiated no more than 6 months prior to randomization.
- For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during active SABR treatment.
- For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during active SABR treatment.
Exclusion
- Pregnancy.
- Contraindications to radiotherapy, including interstitial lung disease if thoracic radiation is planned; Crohn's disease if the gastrointestinal tract will receive radiotherapy; active connective tissue disorders such as scleroderma or uncontrolled lupus; moderate or severe liver dysfunction (Child Pugh B or C) if the patient has liver metastases.
- Prior radiation therapy to an area requiring treatment in the present study, if the composite dose would exceed normal tissue constraints specified by UC San Diego Radiotherapy Standards and Guidelines (published by the Department of Radiation Medicine and Applied Sciences), or by local institutional radiotherapy dose constraints for safety and efficacy.
- Malignant pleural effusion or malignant ascites.
- Leptomeningeal disease in the central nervous system.
- Metastatic disease in a site where it is not possible to safely treat with SABR to the doses specified in the trial.
- Any unresected metastasis \>5 cm in largest diameter or \>3 cm in the brain.
Key Trial Info
Start Date :
November 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2034
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06587490
Start Date
November 12 2024
End Date
November 1 2034
Last Update
October 14 2025
Active Locations (1)
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1
University of California, San Diego
La Jolla, California, United States, 92093