Preop fSRS for Resectable Brain Metastases

Study Purpose

The purpose of the study is to determine whether treatment with pre-operative hypofractionated stereotactic radiosurgery followed by surgery will improve time to local failure (TTLF) compared to the current standard of care.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically confirmed solid tumor malignancy other than lymphoma, or germ cell tumor.
Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician.
  • - Life expectancy must be deemed to be 3 months or more by a neurosurgeon, radiation oncologist, or medical oncologist with expertise in the treatment of metastatic cancer to the brain.
  • - Participants must have MRI evidence of >/=1 brain metastasis no less than 10 mm and no greater than 60 mm in maximum diameter, deemed surgically resectable by neurosurgeon, not previously treated with Stereotactic Radiosurgery (SRS) or appropriate for fSRS.
  • - Each non-index lesion must be
The number of non-index lesions allowed will be at the treating physician's discretion, providing the use of whole brain radiotherapy is not used for treatment of these lesions.
  • - Participants must be either asymptomatic from their brain metastases or have symptoms which are well controlled with steroid medication.
  • - Systemic therapy such as immunotherapy, targeted therapy, or chemotherapy are permitted at treating physician's discretion.
  • - Karnofsky Performance Status (KPS) >/=60.
  • - This study permits the re-enrollment of participant who has discontinued the study due to pre-treatment failure (i.e., the participant has not been treated).
If re-enrolled, participant must be re-consented.
  • - Women of Childbearing Potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to the start of radiation therapy.
  • - Azoospermic males and WOCBP whoa re continuously not heterosexually active are exempt from contraceptive requirements.
However, they must still undergo pregnancy testing as described.
  • - Investigators shall counsel WOCBP and male participants who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy.
Investigators shall advise on the use of highly effective methods of contraception (detailed in protocol), which have a failure rate of <1% when used consistently and correctly.

Exclusion Criteria:

  • - Participants who have germ cell tumors, primary brain tumor, or lymphoma.
  • - Participants with symptoms related to brain metastases not able to be controlled with steroids.
  • - Women who are pregnant or breastfeeding.
  • - Women of childbearing potential who are not using an effective method of contraception.
  • - Participants deemed medically unfit to undergo surgical resection of brain metastasis by the treating neurosurgeon because of medical comorbidities, such as those who are neurologically or hemodynamically unstable despite appropriate medical interventions.
  • - Participants who have had whole brain radiation within the previous three months.
  • - Any prior cranial radiotherapy targeting the index lesion.
  • - Index lesion located in the brainstem.
  • - Any participants with the following imaging findings: Widespread definitive leptomeningeal metastasis Infratentorial mass effect with fourth ventricle effacement or hydrocephalus Supratentorial mass effect with greater than 10 mm of midline shift or hydrocephalus.
A brain metastasis that is located within 2 mm of the optic chiasm.
  • - Active or prior: documented inherited hypersensitivity syndromes, certain collagen vascular diseases, and certain autoimmune diseases.
For example, any radiation hypersensitivity syndrome, including, but not limited to, Gorlin syndrome, multiple sclerosis, ataxia-telangiectasia, scleroderma, and systemic lupus erythematosus.
  • - Inability to complete MRI with contrast of the brain, or a known allergy to gadolinium.
  • - Participants receiving cytotoxic chemotherapies 7 days prior to or concurrently with fSRS.
Note: All other systemic therapies (i.e., molecularly targeted therapies) will be reviewed on a case-by-case basis by study PI to determine if appropriate for study treatment and documented within the research record or EMR.
  • - If participant's treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved.
  • - Inability or unwillingness to return for all the required follow-up visits.
  • - Prisoners or individuals who are involuntarily incarcerated.
- Individuals who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05267587
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael Yu, MD
Principal Investigator Affiliation Moffitt Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Metastases, Brain Lesion
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Hypofractionated Stereotactic Radiosurgery prior to resection

Participants will be given hypofractionated stereotactic radiosurgery (fSRS) in 9 Gray Units (Gy) per fraction x 3 consecutive daily fractions (27 Gy total) to the index metastasis that will be resected on Days 1-3 (3 consecutive days). If there are additional non index brain metastasis, they will be treated with standard stereotactic radiosurgery at the time of fSRS. Participants will then undergo stereotactic craniotomy for surgical resection of the index metastasis within 5 days following completion of fSRS.

Interventions

Radiation: - Hypofractionated Stereotactic Radiosurgery

Participants will be given hypofractionated stereotactic radiosurgery (fSRS) in 9 Gray Units (Gy) per fraction x 3 consecutive daily fractions (27 Gy total) to the index metastasis that will be resected.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Moffitt Cancer Center, Tampa, Florida

Status

Recruiting

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Site Contact

Michelle DeJesus

[email protected]

813-745-6911

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