RECRUITING

Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain

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Conditions

Anatomic Stage IV Breast Cancer AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Metastatic Breast CarcinomaMetastatic Digestive System CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Neoplasm in the BrainMetastatic Malignant Solid NeoplasmMetastatic MelanomaMetastatic Renal Cell CarcinomaStage IV Lung Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.

Official Title

Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases

Quick Facts

Study Start:2024-08-28
Study Completion:2033-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06500455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration:
  2. * Non-small cell lung cancer
  3. * Melanoma
  4. * Breast cancer
  5. * Renal cell carcinoma
  6. * Gastrointestinal cancer
  7. * If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest/abdomen/pelvis, positron emission tomography \[PET\]/CT, prostate-specific membrane antigen \[PSMA\] PET, etc.) is required
  8. * Patients must have at least 1 and up to 8 total intact brain metastases detected on a contrast-enhanced MRI performed ≤ 21 days prior to registration
  9. * At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion with a maximum diameter as measured on any orthogonal plane (axial, sagittal, coronal) of ≥ 1.0 cm and ≤ 3.0 cm
  10. * All brain metastases must be located outside of the brainstem and ≥ 5 mm from the optic nerves or optic chiasm. Note: brainstem metastases per the MRI within 21 days of registration are an exclusion criterion; however, if the MRI used for treatment planning performed within 7 days of SRS/FSRS reveals a brainstem metastasis, the patient remains eligible if the patient is considered an appropriate radiosurgery candidate per the local investigator
  11. * Patients must have a diagnosis-specific graded prognostic assessment ≥ 1.5
  12. * No more than 2 lesions planned for resection if clinically indicated
  13. * No known leptomeningeal disease (LMD)
  14. * Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion
  15. * Age ≥ 18 years
  16. * Karnofsky performance status (KPS) ≥ 60
  17. * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
  18. * No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS, or prophylactic cranial irradiation \[PCI\])
  19. * New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
  20. * No active infection currently requiring intravenous (IV) antibiotic management
  21. * No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  22. * No chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy

Contacts and Locations

Study Contact

Rupesh Kotecha
CONTACT
(786) 999-4267
rupeshk@baptisthealth.net

Principal Investigator

Rupesh R Kotecha
PRINCIPAL_INVESTIGATOR
NRG Oncology

Study Locations (Sites)

Banner University Medical Center - Tucson
Tucson, Arizona, 85719
United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
UC San Diego Health System - Encinitas
Encinitas, California, 92024
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093
United States
City of Hope Antelope Valley
Lancaster, California, 93534
United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
United States
Miami Cancer Institute
Miami, Florida, 33176
United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607
United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, 33544
United States
Centralia Oncology Clinic
Centralia, Illinois, 62801
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126
United States
Edward Hospital/Cancer Center
Naperville, Illinois, 60540
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Springfield Memorial Hospital
Springfield, Illinois, 62781
United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526
United States
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044
United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
United States
Mercy Hospital Springfield
Springfield, Missouri, 65804
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
Community Medical Center
Toms River, New Jersey, 08755
United States
Montefiore Medical Center-Einstein Campus
Bronx, New York, 10461
United States
Montefiore Medical Center-Weiler Hospital
Bronx, New York, 10461
United States
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
United States
Memorial Sloan Kettering Commack
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
United States
Riverside Methodist Hospital
Columbus, Ohio, 43214
United States
NRG Oncology
Philadelphia, Pennsylvania, 19103
United States
Reading Hospital
West Reading, Pennsylvania, 19611
United States
Valley Medical Center
Renton, Washington, 98055
United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501
United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
United States

Collaborators and Investigators

Sponsor: NRG Oncology

  • Rupesh R Kotecha, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-28
Study Completion Date2033-06-30

Study Record Updates

Study Start Date2024-08-28
Study Completion Date2033-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Metastatic Breast Carcinoma
  • Metastatic Digestive System Carcinoma
  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Malignant Neoplasm in the Brain
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Melanoma
  • Metastatic Renal Cell Carcinoma
  • Stage IV Lung Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8