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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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: February 25, 2014
Last verified: February 2014
  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

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 2015
Estimated Primary Completion Date: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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         
Sub-Investigator: Grant Clark, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: John B. Fiveash, MD Hazelrig-Salter Radiation Oncology Center (HSROC)/ University of Alabama at Birmingham (UAB)
  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: February 25, 2014
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 October 16, 2014