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

Tracking Information
First Submitted Date  ICMJE October 30, 2018
First Posted Date  ICMJE October 31, 2018
Last Update Posted Date January 18, 2022
Actual Study Start Date  ICMJE December 25, 2017
Estimated Primary Completion Date January 25, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Study of Fractionated Stereotactic Radiation Therapy
Official Title  ICMJE Phase I TITE-CREM Dose Escalation Study of Fractionated Stereotactic Radiation Therapy (FSRT) in Unresected Brain Metastases
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Brain Metastases
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Radiation: Fractionated Stereotactic Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2018)
43
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 25, 2022
Estimated Primary Completion Date January 25, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alyssa Asaro, BA 718-920-5636 aasaro@montefiore.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03726359
Other Study ID Numbers  ICMJE 2017-8344
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Madhur Garg, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Madhur Garg, MD Montefiore
PRS Account Albert Einstein College of Medicine
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP