We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stereotactic Radiosurgery Dose Escalation for Brain Metastases

This study is currently recruiting participants.
Verified July 2017 by University of Utah
Sponsor:
ClinicalTrials.gov Identifier:
NCT02390518
First Posted: March 17, 2015
Last Update Posted: July 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Utah
  Purpose
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 Intervention
Brain Metastases Radiation: Stereotactic Radiosurgery

Study Type: Interventional
Study Design: 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

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: May 2015
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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.
  • Maximum 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 a maximal 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.
  Contacts and Locations
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: Crelley Mackey 801-581-3916 crelley.mackey@hci.utah.edu

Locations
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Crelley Mackey    801-581-3916    crelley.mackey@hci.utah.edu   
Principal Investigator: Dennis Shrieve, MD         
Sponsors and Collaborators
University of Utah
  Study Documents (Full-Text)

Documents provided by University of Utah:
Study Protocol  [PDF] July 10, 2017
Informed Consent Form  [PDF] July 10, 2017

  More Information

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT02390518     History of Changes
Other Study ID Numbers: HCI71940
First Submitted: March 10, 2015
First Posted: March 17, 2015
Last Update Posted: July 27, 2017
Last Verified: July 2017

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