NCT01891318 Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
| NCT ID | NCT01891318 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | Tumors Metastatic to Brain |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2013-07-03 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2013-07-03 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Inability or unwillingness to return for all the required follow-up visits * At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm * Tumor located in the brainstem * Imaging or cytologic evidence of leptomeningeal disease
Contact & Investigator
Erin Murphy, MD
PRINCIPAL INVESTIGATOR
Case Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT01891318 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tumors Metastatic to Brain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01891318 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT01891318 currently recruiting?
Yes, NCT01891318 is actively recruiting participants. Contact the research team at TaussigResearch@ccf.org for enrollment information.
Where is the NCT01891318 trial being conducted?
This trial is being conducted at Cleveland, United States, Cleveland, United States.
Who is sponsoring the NCT01891318 clinical trial?
NCT01891318 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Erin Murphy, MD at Case Comprehensive Cancer Center. The trial plans to enroll 36 participants.