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

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.
 
ClinicalTrials.gov Identifier: NCT03412812
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
John Fiveash, MD, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: Dose Escalated Five Fraction Stereotactic Radiosurgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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



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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:

  • 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.

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): NCT03412812


Contacts
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Contact: Kristin P Webb, CCRP 205-934-5670 kkwebb@uabmc.edu
Contact: John B Fiveash, MD jfiveash@uabmc.edu

Locations
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United States, Alabama
Hazelrig-Salter Radiation Oncology Center Recruiting
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: John B Fiveash, MD University of Alabama at Birmingham
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Responsible Party: John Fiveash, MD, Assistant Professor - Department of Radiation Oncology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03412812    
Other Study ID Numbers: IRB-300001065
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by John Fiveash, MD, University of Alabama at Birmingham:
Brain Metastases
Stereotactic Radiosurgery
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases