Treatment for oligometastatic cancers using stereotactic ablative radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III randomized study evaluates the effectiveness of stereotactic ablative radiotherapy (SABR) in patients with oligometastatic cancers, where participants are assigned to receive either SABR plus standard care or SABR alone. The primary goal is to measure progression-free survival over two years, with secondary outcomes including overall survival, safety, and the identification of biomarkers that may predict treatment benefits. By focusing on patients with up to ten metastases, the study aims to determine if combining SABR with standard therapies can significantly delay disease progression and improve quality of life. This research builds on previous findings that suggested SABR could enhance survival in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Age at least 18 years.
4. 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).
5. Histopathologic confirmation of a solid malignancy.
6. 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.
7. New systemic therapy for metastatic disease initiated no more than 6 months prior to randomization.
8. 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.
9. For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during active SABR treatment.

Exclusion Criteria:

1. Pregnancy.
2. 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.
3. 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.
4. Malignant pleural effusion or malignant ascites.
5. Leptomeningeal disease in the central nervous system.
6. Metastatic disease in a site where it is not possible to safely treat with SABR to the doses specified in the trial.
7. Any unresected metastasis \>5 cm in largest diameter or \>3 cm in the brain.

Where it's running

• University of California, San Diego
  La Jolla, California, United States Recruiting

Study contacts

• Principal investigator: Tyler Seibert — University of California, San Diego
• Study coordinator: Tyler Seibert, MD, PhD
• Email: cancerCTO@health.ucsd.edu
• Phone: (858) 822-5354

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.