Clinical trial NCT03412812: A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases
Official title: A Phase I Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Brain Metastases
Keywords: Brain Metastases
Stereotactic Radiosurgery
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Maximum Tolerated Dose of Five Fraction Stereotactic Radiotherapy
timeFrame: 1-2 years
Secondary outcomes:
measure: Acute Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire
timeFrame: 1-2 years
measure: Late Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire
timeFrame: 1-2 years
measure: Rate of Local Tumor Control With Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire
timeFrame: 1-2 years
Other outcomes:
measure: Feasibility of Capturing Patient Reported Outcomes Electronically Using FACT-Br Questionnaire
timeFrame: 1-2 years
Locations:
city: Birmingham
country: United States
facility: Hazelrig-Salter Radiation Oncology Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: John B Fiveash, MD
role: PRINCIPAL_INVESTIGATOR
References: