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Systemic Therapy + Stereotactic Radiosurgery for Brain Cancer

Phase 2

Waitlist Available

Led By Thomas H Beckham, MD,PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be free of neurologic signs and symptoms related to metastatic brain lesions either without systemic corticosteroids or requiring ≤ 2 mg dexamethasone daily for symptom resolution

Age ≥ 18 years

Must not have

Subjects previously treated with WBRT

Any intact BM size > 3 cm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if using stereotactic radiosurgery (SRS) can help manage brain metastases in patients who have not fully responded to systemic therapy. It also seeks to compare the effectiveness

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, systemic therapies and stereotactic radiosurgery can cause fatigue, headaches, nausea, skin irritation at treatment sites, and potential cognitive changes depending on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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My cancer has spread to my brain with a detectable tumor.

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I have a brain lesion that has not been treated with radiosurgery.

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I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had whole brain radiation therapy before.

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I have a bone metastasis larger than 3 cm.

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My lung cancer has a specific mutation and I will start targeted therapy.

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My cancer has spread to the lining of my brain and spinal cord.

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I have been treated with SST agents in the last 30 days.

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I had severe side effects from previous SST medication.

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My condition worsened despite treatment with specific cancer drugs.

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My cancer is either small cell lung cancer, lymphoma, or leukemia.

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I had another cancer but was treated successfully and have been cancer-free for 2 years.

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I had a specific brain radiation treatment for a small tumor close to another metastasis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and Adverse Events (AEs).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Radiosurgery

2021

Completed Phase 2

~440

0 / 15Eligibility criteria met