Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00950001
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 132
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 132.6
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This randomized phase III trial studies stereotactic radiosurgery to see how well it works compared to clinical observation after surgery in treating patients with brain metastases. Stereotactic radiosurgery, a type of radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Malignant Neoplasm in the Brain	Radiation: Stereotactic Radiosurgery	Phase 3

Detailed Description

PRIMARY OBJECTIVES:

1. To evaluate benefit of post-surgical stereotactic radiosurgery (SRS) on the resection bed in providing 6 month local control (decreasing the risk of local tumor recurrence) when compared to surgical resection alone.

SECONDARY OBJECTIVES:

1. Overall survival, development of distant brain metastases and complications related to treatment.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo stereotactic radiosurgery to the surgical cavity within 30 days of the craniotomy.

ARM II: Patients undergo clinical observation after craniotomy.

After completion of study treatment, patients are followed up at 5-8 weeks, every 6-9 weeks for 1 year, every 3-4 months for 1 year, and then every 6 months thereafter.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Post-Surgical Stereotactic Radiosurgery for Metastatic Brain Disease: A Randomized Trial
• Actual Study Start Date: Aug 13, 2009
• Anticipated Primary Completion Date: Aug 31, 2020
• Anticipated Study Completion Date: Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (SRS) Patients undergo stereotactic radiosurgery to the surgical cavity within 30 days of the craniotomy.	Radiation: Stereotactic Radiosurgery; Undergo SRS; Other Names: Stereotactic External Beam Irradiation stereotactic external-beam radiation therapy stereotactic radiation therapy Stereotactic Radiotherapy stereotaxic radiation therapy stereotaxic radiosurgery
No Intervention: Arm II (observation) Patients undergo clinical observation after craniotomy.

Outcome Measures

Primary Outcome Measures

1. Time to local recurrence [6 months]

   A univariate test between groups will be conducted using a log rank test of Kaplan-Meier survival estimates and multivariate analyses will be conducted via the Cox proportional hazards model. The hazard ratio comparing each arm will be computed for each endpoint with and without adjustment for other covariates. Confidence intervals (95%) will be computed for the hazard ratio estimates. The proportion of patients experiencing neurological complications will be computed via univariate and multivariate logistic regression analysis.

Secondary Outcome Measures

1. Overall survival [Up to 8 years]

   A univariate test between groups will be conducted using a log rank test of Kaplan-Meier survival estimates and multivariate analyses will be conducted via the Cox proportional hazards model. The hazard ratio comparing each arm will be computed for each endpoint with and without adjustment for other covariates. Confidence intervals (95%) will be computed for the hazard ratio estimates.

2. Development of distant brain metastases [Up to 8 years]

   A univariate test between groups will be conducted using a log rank test of Kaplan-Meier survival estimates and multivariate analyses will be conducted via the Cox proportional hazards model. The hazard ratio comparing each arm will be computed for each endpoint with and without adjustment for other covariates. Confidence intervals (95%) will be computed for the hazard ratio estimates.

3. Incidence of complications related to treatment [Up to 8 years]

   The proportions of patients experiencing neurological complications will be computed via univariate and multivariate logistic regression analysis. The proportion of complications resulting in prolongation of hospital stay will also be computed. The odds ratios comparing both arms will be computed with and without adjustment for other covariates. Confidence intervals (95%) will be computed for the odds ratio estimates.

4. Proportion of patients experiencing neurological complications [Up to 8 years]

   Computed via univariate and multivariate logistic regression analysis.

5. Proportion of complications resulting in prolongation of hospital stay [Up to 8 years]

   Will be computed.

6. Time to first neurological complication [Up to 8 years]

   A univariate test between groups will be conducted using a log rank test of Kaplan-Meier survival estimates and multivariate analyses will be conducted via the Cox proportional hazards model. The hazard ratio comparing each arm will be computed for each endpoint with and without adjustment for other covariates. Confidence intervals (95%) will be computed for the hazard ratio estimates.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients must be older than 3 years of age (radiosurgical frames cannot be placed on children younger than age 3).

2. Patients must have 3 or fewer newly diagnosed metastatic lesions in the brain with a complete resection of at least one lesion as determined the study neuroradiologist.

3. The resection cavity must have a maximum diameter of less than or equal to 4cm. This criteria will be determined by the study radiologist.

4. Additional unresected brain metastases (up to 2) must have a maximum diameter of less than or equal to 3 cm.

5. Patients must be considered candidates for SRS within 30 days of surgical resection.

6. Patients must have a Karnofsky Performance Scores (KPS) of at least 70 at the first post operative visit. Patients under 18 years of age must have a Lansky Performance Score of of at least 70.

7. Patients must be able to undergo an MRI scan.

8. Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form.

Exclusion Criteria:

1. Patients who have received prior radiation therapy to the brain for any reason.

2. There is radiographic evidence of leptomeningeal disease prior to study entry.

3. The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.

4. For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Erik P Sulman, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Texas MD Anderson Cancer Center Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT00950001
• Other Study ID Numbers: 2009-0381; NCI-2011-00542; 2009-0381; P30CA016672
• First Posted: Jul 31, 2009
• Last Update Posted: Jan 2, 2020
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jan 2, 2020