ClinicalTrials.Veeva

Menu

Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors

Mayo Clinic logo

Mayo Clinic

Status and phase

Enrolling
Phase 3

Conditions

Metastatic Malignant Neoplasm in the Brain
Malignant Solid Neoplasm

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03750227
MC167C (Other Identifier)
17-007708
NCI-2018-02799 (Registry Identifier)

Details and patient eligibility

About

This phase III trial studies the side effects and how well stereotactic radiosurgery (SRS) works before or after surgery in patients with tumors that has spread to the brain or that can be removed by surgery. Stereotactic radiosurgery 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.

Full description

PRIMARY OBJECTIVE:

I. To determine for patients with brain metastases meeting the inclusion criteria, whether there is an increase in the time to a composite endpoint of adverse outcomes including the first occurrence of either: local recurrence, leptomeningeal disease, or symptomatic radiation brain necrosis in patients who receive SRS prior to surgery as compared to patients who receive surgery prior to SRS.

SECONDARY OBJECTIVES:

I. To determine for patients with brain metastases whether there is improved overall survival for patients who receive SRS prior to surgery as compared to patients who receive SRS after surgery.

II. To determine for patients with brain metastases whether there are improved patient reported outcomes including quality of life for patients who receive SRS prior to surgery as compared to patients who receive SRS after surgery.

III. To determine if preoperative SRS increases rates of surgical morbidity including postoperative complications such as wound infection, need for longer hospital stays, or readmission compared to a surgery first approach for resectable brain metastases.

IV. To determine for patients with brain metastases whether there is a higher rate of completion of planned therapies for patients who receive SRS prior to surgery as compared to patients who receive surgery prior to SRS.

V. To determine for patients with brain metastases whether there is a shorter time to initiation or re-initiation of systemic therapy with pre-operative versus post-operative SRS.

VI. To determine for patients treated with pre-operative SRS whether there is a longer interval to regional progression, any central nervous system (CNS) progression or need for subsequent intracranial treatment compared to patients receiving post-operative SRS.

VII. To determine for patients with pre-operative as compared to post-operative radiation whether there is a decreased rate of radiation necrosis, including asymptomatic and symptomatic radiation necrosis.

VIII. To determine for patients with pre-operative as compared to post-operative radiation whether there is a decreased rate of local recurrence.

IX. To determine for patients with pre-operative as compared to post-operative radiation whether there is a decreased rate of leptomeningeal disease.

CORRELATIVE RESEARCH OBJECTIVES:

I. To determine the genetic and molecular alterations of brain metastases seen after radiation versus in the setting of resection alone, including early radiobiologic changes in tissue treated with SRS 24 to 48 hours prior, and to investigate detection rate of corresponding circulating deoxyribonucleic acid (DNA) and/or inflammatory markers in peripheral specimens.

II. To investigate the usefulness of biomarkers and response to radiation in predicting local control and outcomes.

III. To look at cell capture of tumor cells as well as cell free DNA in cerebrospinal fluid (CSF) sampled at the time of surgery, comparing patients receiving neoadjuvant treatment to those that have not.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo surgery on day 1. Within 2 weeks, patients undergo stereotactic radiosurgery.

ARM B: Patients undergo stereotactic radiosurgery on day 1. Within 4 weeks, patients undergo surgery.

After completion of study treatment, patients are followed up at 2 weeks, every 3-4 months for up to 2 years and then periodically for up to 3 years.

Enrollment

140 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age >= 18 years
  • Histological or cytological confirmation of solid tumor malignancy and/or clinical history of known or suspected metastatic disease with an intraparenchymal brain tumor consistent with brain metastasis based on clinical and radiologic findings
  • Clinical indication for surgical resection of one brain metastasis based on neurosurgery recommendation and patient deemed a surgical candidate
  • Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (=< 10 metastases)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
  • Provide written informed consent or have a legally authorized representative who is responsible for the care and well-being of the potential study participant, provide consent
  • Willing to continue follow-up visits, either at the enrolling institution or with a local medical doctor as clinically appropriate, and according to the study timeline. Clinical notes and digital copies of imaging must be provided to the enrolling site if follow-up is done externally

Exclusion criteria

  • Any of the following:

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. * NOTE: Patients known to be HIV, but without clinical evidence of an immunocompromised state, are eligible for this trial

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

  • Prior open neurosurgery for malignancy

  • Known or clinically suspected primary germ cell tumor, small cell carcinoma, or lymphoma

  • History of whole brain radiation therapy (WBRT)

  • Known allergy to gadolinium, pacemaker, or other contraindication such as metal implant that is not safe for MRI. Patients with MRI-compatible implants including MRI compatible pacemakers are eligible

  • Leptomeningeal metastasis/disease

  • A brain metastasis that is located =< 5 mm of the optic chiasm

  • Any brain metastasis > 5 cm in size

  • > 10 brain metastases

  • Indication for surgical resection of >= 2 brain metastases

  • Indication for long-term (anticipated greater than 4 weeks) 4 mg dexamethasone equivalent of steroids or bevacizumab

  • Actively enrolled on another brain metastases trial that is assessing the efficacy of either radiation or surgical interventions

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 2 patient groups

Arm A (Post-operative SRS)
Active Comparator group
Description:
Patients undergo surgery on day 1. Within 2 weeks, patients undergo stereotactic radiosurgery.
Treatment:
Other: Questionnaire Administration
Other: Quality-of-Life Assessment
Procedure: Conventional Surgery
Radiation: Stereotactic Radiosurgery
Arm B (Pre-operative SRS)
Experimental group
Description:
Patients undergo stereotactic radiosurgery on day 1. Within 4 weeks, patients undergo surgery.
Treatment:
Other: Questionnaire Administration
Other: Quality-of-Life Assessment
Procedure: Conventional Surgery
Radiation: Stereotactic Radiosurgery

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems