Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05267587
Other study ID # MCC-21193
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 11, 2022
Est. completion date December 1, 2025

Study information

Verified date February 2024
Source H. Lee Moffitt Cancer Center and Research Institute
Contact Michael Yu, MD
Phone 813-745-8741
Email michael.yu@moffitt.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 </= 4.0 cm in maximal extent on contrasted MRI scan, and not otherwise require resection. 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

Study Design


Intervention

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.

Locations

Country Name City State
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Local Control Rate Local control rate is defined as the freedom from local progression at 6 months
Other Local Control Rate Local control rate is defined as the freedom from local progression at 12 months
Other Rate of Leptomeningeal Disease (LMD) Rate of LMD is defined as the percentage of participants that progressed to leptomeningeal disease at 6 months
Other Rate of Leptomeningeal Disease (LMD) Rate of LMD is defined as the percentage of participants that progressed to leptomeningeal disease at 12 months
Other Rate of distant brain recurrence (DBR) Rate of distant brain recurrence defined as the percentage of participants that experienced distant brain recurrence at 6 months
Other Rate of distant brain recurrence (DBR) Rate of distant brain recurrence defined as the percentage of participants that experienced distant brain recurrence at 12 months
Primary Time from Start of fSRS until Progression Time from start of hypofractionated stereotactic radiosurgery until first occurrence of local progression of disease, or death. If none of these events occur, patients will be censored on date of last contact. up to 12 months
Secondary Time from Start of fSRS until First Development of Leptomeningeal Disease or Death Time from start of hypofractionated stereotactic radiosurgery until first development of leptomeningeal disease, or death. If this event does not occur, patients will be censored on date of last contact. up to 12 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04074096 - Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis Phase 2
Recruiting NCT04474925 - Pre- Versus Post-operative SRS for Resectable Brain Metastases Phase 3
Recruiting NCT05358340 - Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions N/A
Recruiting NCT05559853 - Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment
Completed NCT03189381 - Pilot Phase 2 Study Whole Brain Radiation Therapy With Simultaneous Integrated Boost for Patients With Brain Metastases N/A
Completed NCT02082587 - Toronto BNB Pilot Study N/A
Terminated NCT01551680 - A Trial Evaluating Concurrent Whole Brain Radiotherapy and Iniparib in Multiple Non Operable Brain Metastases Phase 1
Terminated NCT00717275 - Study of Temozolomide to Treat Newly Diagnosed Brain Metastases Phase 2
Recruiting NCT05048212 - A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases Phase 2
Recruiting NCT03714243 - Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cancer Brain Metastases N/A
Recruiting NCT05573815 - Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images N/A
Recruiting NCT04899908 - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases Phase 2
Completed NCT04507217 - Tislelizumab Combined With Pemetrexed/ Carboplatin in Patients With Brain Metastases of Non-squamous NSCLC Phase 2
Recruiting NCT05452005 - Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer Phase 1
Recruiting NCT06457906 - SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC Phase 3
Completed NCT04170777 - Perfexion Registration Using CBCT
Recruiting NCT03027544 - Tomotherapy for Refractory Brain Metastases N/A
Completed NCT04178330 - Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases N/A
Terminated NCT02187822 - Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases Phase 1
Terminated NCT00538343 - RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain Metastases Phase 2