Phase I Study of Fractionated Stereotactic Radiation Therapy

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Phase I Study of Fractionated Stereotactic Radiation Therapy

Study Purpose

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. The investigator team thus proposes a Phase I study to determine the feasibility and safety of FSRT in patients with brain metastases.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

- Intact (unresected) brain metastases measuring ≥3 cm and ≤ 6 cm in largest dimension on gadolinium contrast enhanced MRI obtained within 30 days prior to registration OR Surgically resected brain metastasis for which postoperative stereotactic radiotherapy is indicated, with expected target measuring ≥3 cm and ≤6 cm in largest dimension.

- Prior Whole Brain Radiation Therapy (WBRT) is allowed.

- Age ≥ 18 years.

- 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 Stereotactic Radiosurgery (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 (CSF) examination.

- Plan for chemotherapy or targeted agents during treatment.

Hormonal therapy, immunotherapy targeting PD-1/PD-L1 axis, and bone supportive therapy may be continued during treatment.

- 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 lesion with radiotherapy

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03726359
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Albert Einstein College of Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Madhur Garg, MD
Principal Investigator Affiliation	Montefiore Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases

Arms & Interventions

Arms

Experimental: Fractionated Stereotactic Radiation Therapy (FSRT)

This study is unique in that it employs a continuous reassessment methodology (CRM) to determine the Maximum Tolerated Dose. Information for the proper dose level for each subsequent patient enrolled will be determined based on DLTs from previous patients enrolled in the trial.

Interventions

Radiation: - Fractionated Stereotactic Radiation Therapy (FSRT)

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 Stereotactic Body Radiation Therapy (SBRT) schedule is completed within 1.5-2 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Montefiore Medical Center, Bronx, New York

Status

Recruiting

Address

Montefiore Medical Center

Bronx, New York, 10467

Site Contact

Nitin Ohri, MD

[email protected]

718-920-4140