Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative⦠(NCT01757717) | Clinical Trial Compass
CompletedNot Applicable
Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis
United States3 participantsStarted 2013-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ā„ 60
* Age ā„ 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
* Hā¦