Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Phase I Study of Fractionated Stereotactic Radiation Therapy

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. Identifier: NCT03726359
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : January 18, 2022
Information provided by (Responsible Party):
Madhur Garg, Albert Einstein College of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: Fractionated Stereotactic Radiation Therapy Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase I TITE-CREM Dose Escalation Study of Fractionated Stereotactic Radiation Therapy (FSRT) in Unresected Brain Metastases
Actual Study Start Date : December 25, 2017
Estimated Primary Completion Date : January 25, 2022
Estimated Study Completion Date : December 25, 2022

Arm Intervention/treatment
Experimental: Fractionated Stereotactic Radiation Therapy
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.
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.

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: 1 year ]
    The primary endpoint of this study is to determine the maximum tolerated dose (MTD) associated with a 20% dose limiting toxicity (DLT).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT03726359

Layout table for location contacts
Contact: Alyssa Asaro, BA 718-920-5636

Layout table for location information
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Alyssa Asaro, BA    718-920-5636   
Sponsors and Collaborators
Albert Einstein College of Medicine
Layout table for investigator information
Principal Investigator: Madhur Garg, MD Montefiore
Layout table for additonal information
Responsible Party: Madhur Garg, Principal Investigator, Albert Einstein College of Medicine Identifier: NCT03726359    
Other Study ID Numbers: 2017-8344
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: January 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases