Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial

NCT03075072 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 16-305
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 2

Brief Summary

This research study is studying two different types of radiation as treatment for brain metastases (tumors in the brain that spread from a cancer that originated elsewhere in the body)

Conditions

Brain Metastases

Keywords

Brain metastases; Brain metastasis; Lung cancer; Melanoma; Breast cancer; Kidney cancer; Renal cell carcinoma; Stereotactic radiation; Stereotactic radiosurgery; SRS; Stereotactic; Whole brain radiation; WBRT; Hippocampal avoidance; Hippocampal sparing; Hippocampal; Hippocampus; Radiation; Quality of Life; Neurocognitive; Neurocognition; Survival; Salvage; MDASI; Chemotherapy; Recurrence

Outcome Measures

Primary Outcomes (1)

• Quality of Life Survey (symptoms and interference)

  Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)

  6 months

Secondary Outcomes (11)

• Overall survival

  Through study completion, an average of 1 year

• Neurologic survival

  Through study completion, an average of 1 year

• Incidence and time to detection of new brain metastases

  Through study completion, an average of 1 year

• Incidence and time to local recurrence of treated brain tumor(s)

  Through study completion, an average of 1 year

• Incidence and time to development of radiation necrosis

  Through study completion, an average of 1 year

Study Arms (2)

Whole Brain Radiation

ACTIVE COMPARATOR

* MRI will be performed prior to radiation is administered * A hippocampal sparing approach will be used when possible * Dose will be 30 Gy in 10 fractions

Radiation: Whole brain radiation

Stereotactic Radiation (SRS)

EXPERIMENTAL

* MRI will be performed prior to radiation is administered * Radiation will be given in 1-5 fractions (dose depends on the size of the tumor that will be treated)

Radiation: Stereotactic radiation (SRS)

Interventions

Whole brain radiation RADIATION

Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation.

Whole Brain Radiation

Stereotactic radiation (SRS) RADIATION

Focused radiation to each individual brain metastasis without treatment of the remainder of the brain.

Stereotactic Radiation (SRS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have a biopsy proven solid malignancy with untreated (by radiation) intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. Patients who have undergone prior systemic therapy are eligible
• Five-twenty intracranial lesions must be present on MRI of the brain
• Age 18-80 years at diagnosis of brain metastases
• Karnofsky performance status of at least 70

You may not qualify if:

• Participants who have undergone prior radiation for brain metastases.
• Patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study
• Participants who cannot undergo a brain MRI
• Participants who cannot receive gadolinium (MRI contrast)
• Participants with stage IV-V chronic kidney disease or end stage renal disease
• Participants with widespread, definitive leptomeningeal disease
• Participants with small cell lung cancer, lymphoma, or myeloma
• Participants with a maximum tumor diameter exceeding 5 cm (if not resected)

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02116, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Lung Neoplasms; Melanoma; Breast Neoplasms; Kidney Neoplasms; Carcinoma, Renal Cell; Recurrence

Interventions

Radiosurgery; Spermine Synthase

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Breast Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Ayal Aizer, MD MHS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 9, 2017
• Study Start: April 10, 2017
• Primary Completion: November 7, 2024
• Study Completion: September 30, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)