A Phase I Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose of Five Fraction Stereotactic Radiotherapy
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
2.1-4.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. 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. Starting dose level 7 Gy x 5 fractions
Intervention: 8 Gy (Radiation)
2.1-4.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. 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. Starting dose level 7 Gy x 5 fractions
Intervention: 9 Gy (Radiation)
2.1-4.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. 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. Starting dose level 7 Gy x 5 fractions
Intervention: 7 Gy (Radiation)
4.1-6.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. 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. Starting dose level 6 Gy x 5 fractions.
Intervention: 6 Gy (Radiation)
4.1-6.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. 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. Starting dose level 6 Gy x 5 fractions.
Intervention: 7 Gy (Radiation)
4.1-6.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. 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. Starting dose level 6 Gy x 5 fractions.
Intervention: 8 Gy (Radiation)
Outcomes
Primary Outcomes
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 Outcomes
- Acute Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire(1-2 years)
- Late Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire(1-2 years)
- Rate of Local Tumor Control With Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire(1-2 years)
Investigators
John Fiveash, MD
Assistant Professor - Department of Radiation Oncology
University of Alabama at Birmingham