Dose Escalation Trial of Neoadjuvant Radiosurgery for the Treatment of Metastatic Brain Tumors
|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: NCT03163368|
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : December 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases||Radiation: Neoadjuvant stereotactic radiosurgery Procedure: Neurosurgical resection||Early Phase 1|
Radiosurgery is a non-surgical radiation therapy that can deliver targeted radiation to small brain tumors. Radiosurgery is considered to be part of standard of care. Typically for standard of care, radiosurgery is given after a patient has healed from neurosurgery, in an attempt to destroy any cancer cells that may be left after surgery. Patients who agree to participate in this research study will receive radiosurgery before their neurosurgery.
The timing of radiosurgery (pre-operatively) and the dosing to determine the safest dose is considered experimental.
By giving radiation the typical way, after surgery, a larger area of the brain must be covered, which means healthy brain tissue also receives radiation, whereas radiation before surgery will specifically target the tumor.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Dose Escalation Trial of Neoadjuvant Radiosurgery for the Treatment of Metastatic Brain Tumors|
|Actual Study Start Date :||May 9, 2017|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: Neoadjuvant stereotactic radiosurgery
Stereotactic radiosurgery will be performed prior to neurosurgical resection of the indexed brain metastasis. The dose of radiation to be administered to the indexed lesion will be established as a function of tumor size.
Radiation: Neoadjuvant stereotactic radiosurgery
Dose escalation of neoadjuvant stereotactic radiosurgery
Procedure: Neurosurgical resection
Surgical resection of newly diagnosed brain metastases
Other Name: craniotomy
- Maximum tolerated dose (MTD) [ Time Frame: 1 month after neurosurgery ]To determine the maximum tolerated dose of radiosurgery given prior to neurosurgery in subjects with brain metastases of up to 4 cm.
- Adverse events [ Time Frame: 1 month after neurosurgery ]To describe the adverse events associated with radiosurgery when administered prior to neurosurgical resection of brain metastases.
- Describe preliminary rates of image-complete resection [ Time Frame: 3 years ]
- Describe preliminary rates of local tumor control [ Time Frame: 3 years ]
- Describe preliminary rates of intracranial control [ Time Frame: 3 years ]
- Describe preliminary rates of progression-free survival [ Time Frame: 3 years ]
- Describe preliminary rates of leptomeningeal spread [ Time Frame: 3 years ]
- Describe preliminary rates of rate of salvage treatment [ Time Frame: 3 years ]Salvage treatment is any additional local treatment (surgery or radiation) in the setting of recurrent or progressive disease after the current treatment.
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): NCT03163368
|Contact: Cynthia Martin||310-423-2276||Cynthia.Martin@cshs.org|
|United States, California|
|Cedars-Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Cynthia Martin 310-423-2276 Cynthia.Martin@cshs.org|
|Principal Investigator: Stephen Shiao, MD|
|Sub-Investigator: Emi Yoshida, MD|
|Sub-Investigator: Amin Mirhadi, MD|
|Sub-Investigator: Behrooz Hakimian, MD|
|Sub-Investigator: Michele Burnison, MD|
|Sub-Investigator: Zachary Zumsteg, MD|
|Sub-Investigator: Howard Sandler, MD|
|Sub-Investigator: Keith Black, MD|
|Sub-Investigator: Ray Chu, MD|
|Sub-Investigator: Adam Mamelak, MD|
|Sub-Investigator: Chirag Patil, MD|
|Sub-Investigator: John Yu, MD|
|Sub-Investigator: Jethro Hu, MD|
|Sub-Investigator: Jeremy Rudnick, MD|
|Principal Investigator:||Stephen Shiao, MD, PhD||Cedars-Sinai Medical Center|