Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases(RAD 1002)

This study is currently recruiting participants.

Verified January 2013 by University of Alabama at Birmingham

Sponsor:

Information provided by (Responsible Party):

John Fiveash, MD, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT01252797

First received: November 22, 2010

Last updated: January 23, 2013

Last verified: January 2013

History of Changes

Purpose

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.

Condition	Intervention
Brain Metastases	Radiation: Stereotactic Radiosurgery

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	RAD 1002: Phase I Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

to investigate the maximum tolerated dose (MTD) of preoperative stereotactic radiosurgery (SRS) for brain metastasis [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	21
Study Start Date:	October 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group A If the tumor which will be surgically removed is at least 2 cm and up to 4 cm in maximum diameter.	Radiation: Stereotactic Radiosurgery Group A will start at dose level II: 15 Gy Group B will start at dose level I: 12 Gy
Group B If the tumor which will be surgically removed is larger than 4 cm and up to 6 cm in diameter	Radiation: Stereotactic Radiosurgery Group A will start at dose level II: 15 Gy Group B will start at dose level I: 12 Gy

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

patients who have brain metastases and will undergo both surgery and radiation therapy for treatment.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252797

Contacts

Contact: Anna Messer, RN, OCN

205-975-2880

amesser@uabmc.edu

Locations

United States, Alabama
Hazelrig-Salter Radiation Oncology Center/University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35233
Contact: Anna Messer, RN, OCN 205-975-2880 amesser@uabmc.edu
Principal Investigator: John B Fiveash, MD
Sub-Investigator: John Stewart, MD
Sub-Investigator: Sharon Spencer, MD, MSHA
Sub-Investigator: Ruby F. Meredith, MD, PhD
Sub-Investigator: Rojymon Jacob, MD, FCRP
Sub-Investigator: Richard Popple, PhD
Sub-Investigator: Michael C. Dobelbower, MD, PhD
Sub-Investigator: James Markert, MD
Sub-Investigator: Barton Guthrie, MD
Sub-Investigator: Kristin Riley, MD
Sub-Investigator: Winfield Fisher, MD
Sub-Investigator: Alan Cantor, MD

Sponsors and Collaborators

University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:	John Fiveash, MD, Professor and Vice Chair, University of Alabama at Birmingham Department of Radiation Oncology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT01252797 History of Changes
Other Study ID Numbers:	F100528006
Study First Received:	November 22, 2010
Last Updated:	January 23, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:

brain metastases

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes

Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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