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A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases (RAD1705)

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ClinicalTrials.gov Identifier: NCT03412812
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : March 28, 2022
Sponsor:
Information provided by (Responsible Party):
John Fiveash, MD, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE December 29, 2017
First Posted Date  ICMJE January 26, 2018
Last Update Posted Date March 28, 2022
Actual Study Start Date  ICMJE July 30, 2018
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
Maximum tolerated dose of five fraction stereotactic radiotherapy [ Time Frame: 1-2 years ]
To determine the maximum tolerated dose of five fraction stereotactic radiotherapy for patients with either tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
  • Acute toxicity of five fraction stereotactic radiotherapy using Adverse Event questionnaire [ Time Frame: 1-2 years ]
    To assess the acute toxicity of five fraction stereotactic radiotherapy for tumors 2-6 cm in diameter using the RAD 1705 Adverse Events Assessment. This assessment was created within our department and will be used specifically for this study.
  • Late toxicity of five fraction stereotactic radiotherapy using Adverse Event questionnaire [ Time Frame: 1-2 years ]
    To assess the late toxicity of five fraction stereotactic radiotherapy for tumors 2-6 cm in diameter using the RAD 1705 Adverse Events Assessment. This assessment was created within our department and will be used specifically for this study.
  • Rate of local tumor control with five fraction stereotactic radiotherapy using Adverse Event questionnaire [ Time Frame: 1-2 years ]
    To determine the rate of local tumor control with five fraction stereotactic radiotherapy for tumors 2-6 cm in diameter using the RAD 1705 Adverse Events Assessment. This assessment was created within our department and will be used specifically for this study.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 19, 2018)
Feasibility of capturing patient reported outcomes electronically using FACT-Br Questionnaire [ Time Frame: 1-2 years ]
To assess the feasibility of capturing patient reported outcomes with the Functional Assessment of Cancer Therapy-Brain Questionnaire (FACT-Br) electronically in the Radiation Oncology clinic
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases
Official Title  ICMJE A Phase I Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain
Brief Summary This study looks at dose escalation for five fraction stereotactic radiotherapy for patients diagnosed with brain metastases with tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter.
Detailed Description This study looks at dose escalation treatment in patients diagnosed with brain metastases. Treatment involve five fraction stereotactic radiotherapy for patients with brain tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter and dose escalation treatment is delivered only to the single largest tumor while all other tumors are treated with standard of care practices if they are present. A dose escalation schedule is proposed based on the monitoring of CNS toxicity and tumor size of the largest tumor, given it falls into the parameters set on diameter.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain Metastases
Intervention  ICMJE Radiation: Dose Escalated Five Fraction Stereotactic Radiosurgery
As focal radiation techniques are utilized more frequently in the treatment of brain metastases, there is increasing need to accurately define the appropriate patient and tumor characteristics for focal therapy. Unfortunately, not all patients are good candidates for single fraction stereotactic radiosurgery (SRS) since large tumors and those in unfavorable locations have been associated with unacceptable rates of treatment-related toxicity. Five fraction stereotactic radiation has proven to be a more effective treatment for these patients that aren't good candidates.
Study Arms  ICMJE Experimental: Dose Escalated 5 Fraction Stereotactic Radiosurgery
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Tumors must fall into one of two categories: 2.1-4.0cm diameter or 4.1-6.0 cm diameter. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery.
Intervention: Radiation: Dose Escalated Five Fraction Stereotactic Radiosurgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 19, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients must have histologically confirmed malignancy.
  • All patients must have imaging suggestive of one or more brain metastases.
  • Karnofsky performance status (KPS) ≥ 60
  • Age > 18 years
  • Patients must provide written informed consent to participate in the study.
  • Patients must have less than or equal to 10 brain metastases as identified on brain MRI.

Exclusion Criteria:

  • History of surgical resection to the tumor of interest
  • History of radiation to the tumor of interest
  • History of previous whole brain irradiation
  • Receipt of systemic therapy within one week of planned radiation treatment except for hormonal agents.
  • Patient is unable to have MRI or MRI contrast.
  • Inability to meet the appropriate normal tissue dose constraints secondary to tumor location should result in exclusion of the patient / tumor.
  • Patients with a non-index tumor (second tumor) greater than 3 cm in diameter will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kristin P Webb, CCRP 205-934-5670 kkwebb@uabmc.edu
Contact: John B Fiveash, MD jfiveash@uabmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03412812
Other Study ID Numbers  ICMJE IRB-300001065
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Fiveash, MD, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John B Fiveash, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP