Trial for Salvage Re-Irradiation of Metastatic Spine Lesions Using Single-Fraction Stereotactic Radiosurgery
|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: NCT02278744|
Recruitment Status : Recruiting
First Posted : October 30, 2014
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Spine Lesions||Radiation: single-fraction radiation Device: MRI and/or CT||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose Escalation Trial for Salvage Re-Irradiation of Metastatic Spine Lesions Using Single-Fraction Stereotactic Radiosurgery|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
|Experimental: single-fraction radiosurgery||
Radiation: single-fraction radiation
Patients enrolled on this study will be registered into a dose tier and undergo 1 session of image-guided SRS using techniques previously. Three escalating SRS spinal cord/cauda maximum dose (Dmax) levels (14 Gy, 16 Gy, and 17 Gy) will be evaluated to determine the safety of this approach. A minimum of three patients will be treated per dose tier. Toxicity based on NCI CTCAE (v4). Post treatment followup at 2 and 4 months (+/- 2 weeks) post-treatment, at 6 months (+/- 4 weeks) and then every 3 months until 2 years (± 4 weeks). Followup schedule based on last day of treatment. No schedule adjustments based on early or delayed visits.
Other Name: stereotactic radiosurgery (SRS)
Device: MRI and/or CT
- toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria [ Time Frame: 1 year ]The toxicities associated with single fraction stereotactic radiosurgery to the spine may be classified as either early (occurring within 90 days of the treatment) or late toxicities (after 90 days to 1 year). These toxicities will be evaluated with the National Cancer Institute (NCI) Common Toxicity Criteria.
- local failure [ Time Frame: 1 year ]tumor control will be defined for this study as the absence of tumor progression at the treated site, where progression may consist of an increase in maximal dimension of the tumor by ≥20%, compromise of the spinal cord/cauda equina and/or exiting spinal nerves (assessed clinically or radiographically), or both.
- overall survival [ Time Frame: 2 years ]will be evaluated from the completion of treatment, and analyzed by the Kaplan-Meier method or cumulative incidence curves. For these outcomes, patients across all dose levels will be combined, and will only be evaluated for a maximum of 2 years on protocol.
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): NCT02278744
|Contact: Yoshiya Yamada, MD||212-639-2950|
|Contact: Mark Bilsky, MD||212-639-8526|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Yoshiya Yamada, MD 212-639-2950|
|Contact: Mark Bilsky, MD 212-639-8526|
|Principal Investigator: Yoshiya Yamada, MD|
|Principal Investigator:||Yoshiya Yamada, MD||Memorial Sloan Kettering Cancer Center|