Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-13

Study Completion Date

2027-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases

NCT03741673

Malignant Neoplasm Metastatic Malignant Neoplasm in the Brain

RECRUITING PHASE3

Surgery Versus Stereotactic Radiosurgery in the Treatment of Single Brain Metastasis: A Randomized Trial

NCT00460395

Brain Cancer

COMPLETED PHASE3

Stereotactic Radiosurgery or Whole Brain Radiation Therapy in Treating Patients With Newly Diagnosed Non-melanoma Brain Metastases

NCT01592968

Metastatic Malignant Neoplasm Metastatic Malignant Neoplasm in the Brain

ACTIVE_NOT_RECRUITING PHASE3

Radiation Therapy With or Without Radiosurgery in Treating Patients With Brain Metastases

NCT00002708

Metastatic Cancer

COMPLETED PHASE3

Randomized Trial Comparing Radiosurgery With vs Without Whole Brain Radiotherapy

NCT00548756

Brain Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Malignant Neoplasm in the Brain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I (SRS)

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

Group Type EXPERIMENTAL

Stereotactic Radiosurgery

Intervention Type RADIATION

Undergo SRS

Arm II (observation)

Patients undergo clinical observation after craniotomy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stereotactic Radiosurgery

Undergo SRS

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Stereotactic External Beam Irradiation stereotactic external-beam radiation therapy stereotactic radiation therapy Stereotactic Radiotherapy stereotaxic radiation therapy stereotaxic radiosurgery

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No