Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis
This trial is active, not recruiting.
|Conditions||metastatic or recurrent lesions in the spine, metastatic or recurrent lesions in the pelvis|
|Treatment||ir-192 high dose rate (hdr)|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Start date||January 2013|
|End date||December 2017|
|Trial size||20 participants|
|Trial identifier||NCT01757717, 12-260|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Primary purpose||supportive care|
feasibility of High Dose Rate (HDR) treatment
time frame: 1 year
Toxicity of HDR brachytherapy
time frame: 1 year
Male or female participants at least 18 years old.
Inclusion Criteria: - Patients must have histologic proof of a malignancy suitable for radiation therapy. - Patients must have received prior external beam radiation therapy to the region proposed for HDR brachytherapy treatment; evaluation of doses previously delivered to spinal cord/cauda equine, pelvis, and other critical structures (bowel, kidneys, rectum) will be taken into consideration. - If repeat irradiation would exceed any normal tissue constraint set by MSKCC Radiation Oncology Department dose constraint criteria, the patient will potentially be eligible. - If the total prior radiation dose to the cord or pelvis exceeds 100 Gy BED equivalent, the patient will be potentially eligible, where a total of 100 BED Gy equivalent is determined by the biological equivalent dose (BED) calculation; BED = nd(1 + d/α/β), where n = number of fractions and d = dose per fraction; α/β is the constant for spinal cord late effect and equals 2. [Rades 2005, Nieder 2005, Sahgal 2012] - KPS ≥ 60 - Age ≥ 18 years old Exclusion Criteria: - Patients who may receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by MSKCC Radiation Oncology Department dose constraint criteria. - Patients with kyphoplasty cement or hardware that would preclude effective catheter placement. - Patients with paraspinal extension of disease with visceral involvement. - Abnormal complete blood count. Any of the following: - Platelet count < 75,000/ml - Hb level < 9gm/dl - WBC < 3.5/ml - Abnormal coagulation profile: INR > 2.5 and/or PTT > 80 - Patients who are on anticoagulation medication that may not be safely held for the procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded. - Contraindications to general anesthesia
|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|
|Principal investigator||Yoshiya Yamada, MD|
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