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 : December 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases||Radiation: Fractionated Stereotactic Radiation Therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||December 25, 2021|
|Estimated Study Completion Date :||December 25, 2022|
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.
- 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).
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 ClinicalTrials.gov identifier (NCT number): NCT03726359
|Contact: Alyssa Asaro, BAemail@example.com|
|United States, New York|
|Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10467|
|Contact: Alyssa Asaro, BA 718-920-5636 firstname.lastname@example.org|
|Principal Investigator:||Madhur Garg, MD||Montefiore|