Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis
The purpose of this study is to see if using a form of imaging during surgery helps the doctors to guide the placement of radiation catheters more accurately.
This method, called "image-guided surgical navigation" may allow the doctors to deliver radiation to the tumor that the patient needs and decrease the amount of radiation delivered to the nearby areas.
|Metastatic or Recurrent Lesions in the Spine Metastatic or Recurrent Lesions in the Pelvis||Radiation: Ir-192 high dose rate (HDR)|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Pilot Study of Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis|
- feasibility of High Dose Rate (HDR) treatment [ Time Frame: 1 year ]
of spine and/or pelvis lesions using catheters placed under image guided navigational techniques, to provide improved dosimetric coverage of spinal lesions such that.
In terms of technical feasibility, a patient is regarded as being successfully treated if the target D90 is ≥ 80% AND the cord/cauda max dose is 8 Gy.
- Toxicity of HDR brachytherapy [ Time Frame: 1 year ]for previously irradiated lesions of the spine and/or pelvis, defined as an acceptable level of severe toxicity (both acute and late effects) in the setting of HDR brachytherapy treatment. Severe toxicity will be defined as ≥ grade 3 NCI CTCAE v 4.0 toxicity that is at least possibly related to treatment
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Ir-192 high dose rate (HDR)
This pilot study is an investigation into the use of Ir-192 high dose rate (HDR) afterloader-based brachytherapy with catheter placement using image-guided surgical navigation techniques for patients with painful/symptomatic metastatic or recurrent lesions in the spine and/or pelvis that have been maximally treated with external beam radiation therapy.
Radiation: Ir-192 high dose rate (HDR)
Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757717
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Yoshiya Yamada, MD||Memorial Sloan Kettering Cancer Center|