EXCLAIM: Exploring Combined Local and Systemic Approaches In Brain Metastasis: a Multi-cohort Randomized Phase II Study Evaluating Initial Response to Systemic Therapy and Subsequent Integration of Stereotactic Radiosurgery in Patients With Low-risk Brain Metastases and Central Nervous System-active

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About 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 does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Evaluation by a brain metastasis multidisciplinary team (BM-MDT) consisting of a medical oncologist (can be the patient's primary medical oncologist), a radiation oncologist who regularly performs SRS, and a neurosurgeon. This evaluation can take place in clinic or during a multidisciplinary conference.

Life expectancy > 6 months as estimated by BM-MDT.

BM-MDT agreement that the planned systemic therapy regimen may provide intracranial benefit (SD, PR, or CR in the CNS).

Disqualifiers

History of known leptomeningeal involvement (radiographic or cytological).

Small cell lung cancer, lymphoma, or leukemia histology.

Non-small cell lung cancer histology with targetable oncogenic driver mutation with planned initiation of highly CNS active targeted therapy (eg osimertinib, brigatinib, alectinib, or lorlatinib).

Subjects previously treated with WBRT.

Trial design

Design model

Single group

Treatments tested in this trial

  • Systemic Therapy

    Other intervention

    Participants will receive systemic therapy as a standard of care therapeutic option

  • Stereotactic Radiosurgery

    Radiation

    Participants will receive systemic therapy as a standard of care therapeutic option

Treatment groups

316 Participants
are divided into 5 treatment groups
Group A: cSRS PR or SDExperimental treatment 2 interventions
Group B: a-pdSR CNS PDExperimental treatment 2 interventions
Group C: b-PDC CNS PDExperimental treatment 2 interventions
Group D: SST treated SD or PR patients to receive cSRS/ ongoing observationExperimental treatment 2 interventions
Group E: SST treated PD patients to pdSRS / pdSRS+cSRSExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs).

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.