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Stereotactic Radiosurgery Dose Escalation for Brain Metastases

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ClinicalTrials.gov Identifier: NCT02390518
Recruitment Status : Recruiting
First Posted : March 17, 2015
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
University of Utah

Brief Summary:
This is a Phase I dose escalation trial. The purpose of this study is to determine the maximum tolerated dose of radiation received during stereotactic radiosurgery in patients with brain metastases who have never received radiation to the brain before.

Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: Stereotactic Radiosurgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Stereotactic Radiosurgery Dose Escalation for Brain Metastases
Actual Study Start Date : May 5, 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Experimental: Stereotactic Radiosurgery Radiation: Stereotactic Radiosurgery

Patients with 1 to 5 brain metastases will be treated. Patients will be assigned to one of four cohorts based on the size of their brain lesions. For each patient, a single lesion will be treated at experimental dose level, other metastases (if present) will receive standard SRS doses.

Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Cohort 1a Diameter: ≤ 10 mm Volume: ≤ 0.5236 cm3 26 Gy 28 Gy 30 Gy n/a Cohort 1b Diameter: 11-20 mm Volume: 0.5237-4.1888 cm3 26 Gy 28 Gy 30 Gy n/a Cohort 2 Diameter: 21-30 mm Volume: 4.1889-14.1372 cm3 20 Gy 22 Gy 24 Gy n/a Cohort 3 Diameter: 31-40 mm Volume: 14.1373-33.5103 cm3 17 Gy 19 Gy 21 Gy 23 Gy

Dose Escalation A non-standard 5+4 design will be used for the dose escalation. For each cohort, an initial group of 5 patients will be accrued at dose level 1 and receive experimental treatment to one of their lesions.

Other Name: SRS




Primary Outcome Measures :
  1. Maximum Tolerated Dose of stereotactic radiosurgery [ Time Frame: Maximum Tolerated Dose of stereotactic radiosurgery will be evaluated throughout the treatment period which is expected to last 12 weeks per patient ]
    Patients will be evaluated for any grade 3 or greater toxicities attributed to the lesion treated with the escalated dose



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically confirmed brain metastases by CT or MRI criteria. If there is evidence of extra-cranial metastatic disease, it is preferable that the lesions be pathologically confirmed (see section 4.2.5 for excluded histologies) and reviewed by a University of Utah or Huntsman Cancer Hospital pathologist if the initial review was done at an outside facility.
  • Prior brain surgery is allowed, although a lesion situated in the operative bed would not be selected to receive an experimental dose of SRS treatment. SRS should be delivered 4-6 weeks post-surgery if the patient had a craniotomy for resection of a lesion. Enrollment of a patient with the goal of performing SRS outside of the 4-6 post-craniotomy window is at the PI's discretion.
  • Patients must have 1-5 brain metastases total.
  • Equivalent tumor diameter ≤ 40 mm by CT or MRI measurement at the time of consultation/screening (for each metastatic lesion present in the brain).
  • All metastatic lesions must be separated by a minimum of 3 cm as measured from the peripheral edges of the lesions which are in closest proximity to one another. If multiple lesions are present and are not all ≥ 3 cm away from each other, the patient will be deemed ineligible.
  • Prior systemic therapy is allowed, although appropriate washout is required for patients who have been on BRAF inhibitors (at least 7 days).
  • For subjects currently on active systemic cancer therapy, the treating medical oncologist should be consulted to ensure proper washout (if appropriate) periods prior to SRS.
  • Patients must be at least 18 years of age.
  • Karnofsky Performance Status (KPS) ≥ 60.
  • Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.
  • Women of child-bearing potential must have a negative pregnancy test within 10 days of study enrollment and must agree to use an acceptable method of birth control while receiving radiation and for 3 months after radiation. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for >1 year.
  • Men who are able to father a child must agree to use an acceptable method of birth control while receiving radiation, and for 3 months after radiation.

Exclusion Criteria:

  • Prior whole/partial brain irradiation or stereotactic radiosurgery
  • Brain lesions with an equivalent diameter of > 40 mm in size on MRI imaging at the time of consultation/screening for protocol eligibility.
  • Lesion located in anatomic regions that are not amendable to SRS, including the brain stem, optic apparatus, or eloquent cortex
  • Radiographic or cytologic evidence of leptomeningeal disease
  • Primary lesion with radiosensitive histology that includes the following: small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma
  • Women of child-bearing potential who are pregnant or breast feeding
  • Patients with multiple lesions, which by size criteria would be enrolled in a cohort which is full at the time of enrollment and the 12 weeks DLT period has not been reached.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390518


Contacts
Contact: Brett Johnson 801-587-4429 Brett.Johnson@hci.utah.edu
Contact: Clinical Trials Office 801-585-0255

Locations
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Brett Johnson    801-587-4429    Brett.Johnson@hci.utah.edu   
Principal Investigator: Dennis Shrieve, MD         
Sponsors and Collaborators
University of Utah

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT02390518     History of Changes
Other Study ID Numbers: HCI71940
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms
Brain Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases