OBSERVE: A Pilot Study Of Omission Of Brain Metastasis Stereotactic Radiosurgery Following Resection With CNS-Active Systemic Therapy

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To remove a brain tumor, patients usually receive radiation to lower the chance that the cancer will come back in the spot where the tumor was removed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

ECOG performance status ≤ 2.

Participants with a resected brain metastasis with gross total resection and pathologic confirmation of NSCLC or melanoma. Gross total resection must be confirmed based on a review of the operative report, pathology, and all post-operative images available at the time of enrollment.

Brain metastasis resection occurred ≤ 5 weeks ago.

Disqualifiers

History of known leptomeningeal involvement (radiographic or cytological).

Subjects that have previously received or are currently planned for whole brain radiotherapy.

Prior unacceptable toxicity on one or more of the agents comprising the planned study systemic therapy.

Cognitively impaired subjects with a major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled.

Trial design

Design model

Single group

Treatments tested in this trial

  • Systemic therapy

    Other intervention

    Systemic therapy regimen consisting of one of the following: dual-agent immune checkpoint inhibitors (e.g. ipilimumab and nivolumab) for melanoma, osimertinib for EGFR Mutant NSCLC, and brigatinib, alectinib, or lorlatinib for ALK rearranged/fusion positive NSCLC.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: systemic therapyExperimental treatment 1 intervention

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

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