Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center

About this trial

This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies

Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion > 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS

Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection

Patient must have a Karnofsky performance score of ≥ 70

Disqualifiers

Patient deemed medically unfit to undergo surgical resection of brain metastasis

Prior whole brain radiotherapy

Patient with contraindication for imaging with MRI

Inability to participate in study activities due to physical or mental limitations

Trial design

Design model

Single group

Treatments tested in this trial

  • radiosurgery

    Radiation

    Undergo radiosurgery

  • therapeutic conventional surgery

    Procedure/Surgery

    Undergo surgical resection

  • quality-of-life assessment

    Procedure/Surgery

    Ancillary studies

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Treatment (radiosurgery, surgery)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Maximum tolerated dose (MTD)

MTD of radiosurgery determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 (Phase I)

Time frame
Day 0
2

Proportion of participants without local failure (Phase II)

Local control of brain metastases, as measured by proportion of participants without local failure (Local failure is tumor progression of the metastasis treated on the study) (Phase II) The Kaplan-Meier method will be used.

Time frame
Up to 3 years

Secondary outcomes

1

Proportion of participants with distant brain failure

Rate of distant brain failure, defined as progression of brain metastases outside of the brain metastasis treated on study. The Kaplan-Meier method will be used.

Time frame
Up to 3 years
2

Rate of radiation necrosis/steroid dependency

Rate of radiation necrosis/steroid dependency

Time frame
Up to 3 years
3

Rate of salvage treatment

Number of patients that have any salvage treatment, including surgery, stereotactic radiosurgery (SRS), or whole brain radiation therapy (WBRT)

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

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