SABR for Oligometastatic Cancer
(SABR-COMET 10 Trial)

Recruiting in Palo Alto (17 mi)

+13 other locations

Dr. David Palma - Ontario Institute for ...

Overseen bySuresh Senan, MRCP, FRCR

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: David Palma

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

In patients with a limited oligometastatic burden (cancer has spread but is not yet considered metastatic), emerging evidence suggests that treatment of all sites of disease with ablative therapies can improve patient outcomes, including overall- and progression-free survival. The application of Stereotactic Ablative Radiotherapy (SABR) for patients with 4-10 metastatic deposits appears promising, yet it is unclear if all patients with greater than 3 oligometastatic lesions benefit from ablative therapies in terms of improved Overall Survival (OS), Progression Free Survival (PFS), or quality of life. The purpose of this study is to assess the impact of SABR, compared to standard of care treatment, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumor and 4-10 metastatic lesions.

Eligibility Criteria

This trial is for adults with cancer that has spread to 4-10 places but isn't widespread. They must have had their original tumor controlled for at least 3 months, be able to undergo treatment safely, and have a life expectancy over 6 months. It's not for those with large tumors in certain areas, brainstem involvement, spinal cord compression, or serious health issues that radiotherapy could worsen.

Inclusion Criteria

All my cancer areas can be safely treated.

I can care for myself but may need occasional help.

My original cancer site has been stable for at least 3 months after treatment.

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Exclusion Criteria

My cancer has spread to my digestive system, certain lymph nodes, or skin.

My cancer has spread to the brainstem.

Pregnant or lactating women

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Treatment Details

Interventions

Stereotactic Ablative Radiotherapy (Radiation Therapy)

Trial OverviewThe study tests if Stereotactic Ablative Radiotherapy (SABR) can improve survival and quality of life compared to standard treatments like chemotherapy or observation in patients with limited metastatic cancer. Participants will either receive SABR or the standard care to see which is more effective.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Stereotactic ArmExperimental Treatment5 Interventions

Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.

Group II: Standard armActive Control5 Interventions

Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.

Stereotactic Ablative Radiotherapy is already approved in European Union, United States, Australia, United Kingdom for the following indications:

🇪🇺 Approved in European Union as Stereotactic Ablative Radiotherapy for: