Overview

This trial is active, not recruiting.

Condition brain metastases
Treatment stereotactic radiosurgery
Sponsor University of Alabama at Birmingham
Start date October 2010
End date November 2016
Trial size 20 participants
Trial identifier NCT01252797, F100528006

Summary

This study will investigate the safety, tolerability, and effectiveness of changing the order of receiving radiation therapy for treating brain cancer. The investigators hope that changing the sequence of radiation therapy will lower the risk of cancer spreading throughout your spinal fluid, which covers your brain and spinal cord.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
If the tumor which will be surgically removed is at least 2 cm and up to 4 cm in maximum diameter.
stereotactic radiosurgery
Group A will start at dose level II: 15 Gy Group B will start at dose level I: 12 Gy
If the tumor which will be surgically removed is larger than 4 cm and up to 6 cm in diameter
stereotactic radiosurgery
Group A will start at dose level II: 15 Gy Group B will start at dose level I: 12 Gy

Primary Outcomes

Measure
to investigate the maximum tolerated dose (MTD) of preoperative stereotactic radiosurgery (SRS) for brain metastasis
time frame: one year

Secondary Outcomes

Measure
to evaluate acute toxicity, late toxicity, technical feasibility, and to estimate rates of local control and leptomeningeal dissemination with preoperative stereotactic radiosurgery (SRS).
time frame: 2 years

Eligibility Criteria

Male or female participants at least 19 years old.

Inclusion Criteria: - All subjects must have history of histologically confirmed malignancy. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician. - Newly diagnosed brain metastases (four or fewer by post-contrast MRI obtained within six weeks of study entry) - At least one brain metastasis (index tumor) must be within 2-6 cm in maximum diameter and deemed appropriate for surgical resection by the treating neurosurgeon. - Karnofsky performance status (KPS) of greater than or equal to 60 (Appendix B) - Age greater than 19 - Life expectancy greater than 12 weeks - Subjects given written informed consent Exclusion Criteria: - Patients with small cell lung cancer and lymphoma are ineligible. - More than four metastases by baseline post-contrast MRI - Prior whole brain radiation therapy - Insufficient recovery from all active toxicities of prior therapies - Subjects who are deemed to be poor surgical risks by the treating neurosurgeon because of medical comorbidities - Pregnant or nursing women - Women of childbearing potential who are not using an effective method of contraception are excluded. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to administration of SRS.

Additional Information

Official title RAD 1002: Phase I Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases
Principal investigator John B. Fiveash, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.