Stereotactic Radiation Therapy Before Surgery for the Treatment of Resectable Brain Metastases

NCT04069910 | Withdrawn DMC FDA Device

• 2 other identifiers: 17-000082NCI-2019-05337
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how well stereotactic radiation therapy before surgery works in treating patients with cancer that has spread to the brain (brain metastases) and can be removed by surgery (resectable). Stereotactic radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor, and may cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery may make the return of brain metastases less likely and help patients live longer compared to surgery followed by radiation therapy.

Conditions

Malignant Neoplasm, Brain; Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Rate of leptomeningeal failure

  A two-sided Z test with pooled variance will be used at significance level =0.1 to test if there is a difference in leptomeningeal failure rate between the two treatment groups.

  Up to 2 years

Secondary Outcomes (9)

• Time to progression

  Up to 2 years

• Rate of salvage treatment including surgery, SRS, SRT, or WBRT

  Up to 2 years

• Dose (Gy) and volume (cc) of radiation to adjacent normal brain parenchyma

  Up to 2 years

• Rate of symptomatic radiation necrosis/steroid dependency

  Up to 2 years

• Rate of distant brain failure

  Up to 2 years

Study Arms (2)

Arm A (SRS/SRT, surgery)

EXPERIMENTAL

Patients undergo 1, 5, or 10 fraction of SRS/SRT radiation. Surgery is performed within 72 hours of radiation therapy.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery; Procedure: Therapeutic Conventional Surgery

Arm B (surgery, SRS/SRT)

ACTIVE COMPARATOR

Within 2-5 weeks after standard of care surgery, patients undergo 1, 5, or 10 fraction of SRS/SRT.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery; Procedure: Therapeutic Conventional Surgery

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (SRS/SRT, surgery); Arm B (surgery, SRS/SRT)

Questionnaire Administration OTHER

Ancillary studies

Arm A (SRS/SRT, surgery); Arm B (surgery, SRS/SRT)

Stereotactic Radiosurgery RADIATION

Undergo SRS/SRT

Also known as: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery

Arm A (SRS/SRT, surgery); Arm B (surgery, SRS/SRT)

Therapeutic Conventional Surgery PROCEDURE

Undergo standard of care surgery

Arm A (SRS/SRT, surgery); Arm B (surgery, SRS/SRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
• ?4 cerebral metastases per magnetic resonance imaging (MRI) with at least 1 being dominant and eligible for resection
• No prior radiation treatment for the index brain metastases
• Systemic disease staged within previous 8 weeks and not rapidly progressing, with concern of life expectancy \> 3 months
• The patients will have been evaluated by the multidisciplinary team, and surgery must be deemed necessary as a result of indications including but not limited to mass effect or symptomatic lesion. Surgery must be deemed non?emergent or non?urgent clinically by the neurosurgeon
• Karnofsky performance status (KPS) \>= 70
• No active infections requiring systemic antibiotics
• If a woman is of childbearing potential, a negative serum pregnancy test must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study treatment
• Ability to understand and willingness to sign a written informed consent

You may not qualify if:

• Patient deemed medically unfit to undergo surgical resection of brain metastasis
• Prior whole brain radiotherapy
• Patient with contraindication for imaging with MRI
• Surgery is considered emergent or urgent by the neurosurgeon due to symptoms or concerning mass effect noted on imaging
• Patients who are participating in a concurrent treatment protocol
• At the time of planning, unable to meet dose tolerance of the optic nerve/chiasm
• Tumor located in the brainstem
• Imaging or cytologic evidence of leptomeningeal disease
• Concurrent uncontrolled illness including, but not limited to, any of the following: Symptomatic congestive heart failure, unstable angina pectoris, psychiatric illness

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tania B Kaprealian, MD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 28, 2019
• Study Start: August 26, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: January 31, 2022

Record last verified: 2020-09

Locations

US (1)