Phase I Study of Fractionated Stereotactic Radiation Therapy

Brain Metastases Clinical Trial

Official title:

Phase I TITE-CREM Dose Escalation Study of Fractionated Stereotactic Radiation Therapy (FSRT) in Unresected Brain Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03726359
• Other study ID #: 2017-8344
• Status: Recruiting
• Phase: Phase 1
• Start date: December 25, 2017
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: Albert Einstein College of Medicine
• Contact: Alyssa Asaro, BA
• Phone: 718-920-5636
• Email: aasaro[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is a lack of prospective trial data and consensus guidelines describing the use of Fractionated Stereotactic Radiation Therapy (FSRT) in the treatment of brain metastases. There has been no prospective dose escalation study performed to date to determine the maximum tolerated dose (MTD) in patients treated with FSRT. Prescription doses in the series described above ranged from 18 Gy to 42 Gy, delivered in 3 to 12 fractions. The results of this study will be used to plan future Phase II/III studies to determine the efficacy of different dose fractionation schedules of FSRT. We thus propose a phase I study to determine the feasibility and safety of FSRT in patients with brain metastases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathologically proven diagnosis of a non-hematological malignancy other than small cell lung cancer within 5 years of registration.

• Patients with measurable brain metastases who have a gadolinium contrast enhanced MRI obtained within 30 days prior to registration. Patients with CT based diagnostic imaging without MRI will not be allowed to enroll on this trial.

• No surgical resection of the target lesion, defined as =3 cm but =6 cm in size on MRI of the Brain with contrast

• Prior Whole Brain Radiation Therapy (WBRT) is allowed

• Age = 18 years

• Karnofsky performance status = 60 or ECOG =2

• Women of childbearing potential and male participants must practice adequate contraception

• History/Physical examination within 30 days prior to registration

• Life expectancy>3 months

• Patients are allowed to enroll if previously treated to other lesions with SRS

• Patients with multiple lesions are allowed, as long there is one dominant lesion that will be treated with FSRT. Other lesions may be treated concurrently with SRS or FSRT at the discretion of the treating physician but will not contribute to the study endpoints.

Exclusion Criteria:

• Patients with definitive leptomeningeal metastases, based on cerebrospinal fluid examination (CSF)

• Plan for chemotherapy or targeted agents during treatment. All hormonal therapy and bone supportive therapy may be continued while patient is on study.

• Contraindication to enhanced MRI imaging such as implanted metal devices. However, patients with implanted devices which are MRI compatible are allowed.

• Patients with measurable brain metastasis resulting from small cell lung cancer and germ cell malignancy

• Uncontrolled intercurrent illness such as congestive heart failure, unstable angina, cardiac arrhythmia, and uncontrolled seizure activity.

• Previous treatment of the target lesions with radiotherapy.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• Fractionated Stereotactic Radiation Therapy
Initial starting dose will be 7 Gy x5= 35 Gy delivered to the planning target volume (PTV). Radiotherapy will be delivered every other day so that the SBRT schedule is completed within 1.5-2 weeks.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD)	The primary endpoint of this study is to determine the maximum tolerated dose (MTD) associated with a 20% dose limiting toxicity (DLT).	1 year