Systemic Therapy + Stereotactic Radiosurgery for Brain Cancer

Recruiting in Palo Alto (17 mi)

Overseen byThomas H Beckham, MD,PHD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?To learn if consolidative stereotactic radiosurgery (cSRS) can help to control central nervous system (CNS) disease in patients who have brain metastases and have a partial response or stable brain metastases after systemic therapy. To learn if using SRS to treat all brain metastases that do not respond to systemic therapy versus treating only metastases that are getting worse can help to control CNS disease in patients whose disease gets worse after systemic therapy.

Eligibility Criteria

This trial is for patients with brain metastases who have had a partial response or stable condition after systemic therapy. It's not specified who can't join, but typically those with certain medical conditions or treatments that conflict with the study may be excluded.

Inclusion Criteria

My medical team agrees my bone marrow doesn't need immediate treatment.

I don't have brain-related symptoms from cancer, or I manage them with a low dose of steroids.

I have been evaluated by a team of cancer and brain surgery specialists.

+12 more

Exclusion Criteria

Any BM with a significant hemorrhagic component

I have had whole brain radiation therapy before.

I have a bone metastasis larger than 3 cm.

+12 more

Participant Groups

The study is testing if stereotactic radiosurgery (cSRS) can control central nervous system disease in patients whose brain metastases are partially responsive or stable following systemic therapy, and comparing different SRS approaches to treat progressing metastases.

5Treatment groups

Experimental Treatment

Group I: cSRS PR or SDExperimental Treatment2 Interventions

Patients with a CR will be observed with ongoing standard of care MRI. Patients with SD or PR will be randomized to receive cSRS or ongoing observation.

Group II: b-PDC CNS PDExperimental Treatment2 Interventions

At the time of CNS PD, patients will also be randomized to pdSRS versus pdSRS + cSRS.

Group III: a-pdSR CNS PDExperimental Treatment2 Interventions

At the time of CNS PD, patients will also be randomized to pdSRS versus pdSRS + cSRS.

Group IV: SST treated SD or PR patients to receive cSRS/ ongoing observationExperimental Treatment2 Interventions

Patients with a CR will be observed with ongoing standard of care MRI. Patients with SD or PR will be randomized to receive cSRS or ongoing observation.

Group V: SST treated PD patients to pdSRS / pdSRS+cSRSExperimental Treatment2 Interventions

At the time of CNS PD, patients will also be randomized to pdSRS versus pdSRS + cSRS.