Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
Ir-192 high dose rate (HDR)	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.

Primary Outcome Measures

Name	Time	Method
Maximum Radiation Dose	1 year	Verify feasibility of HDF treatment of spinal and/or pelvic lesions using catheters placed under image-guided navigational techniques, to provide improved dosimetric coverage of lesions such that Cord/Cauda Dmax of \<8 Gy

Secondary Outcome Measures

Name	Time	Method
Number of Grade 3 of Higher Toxicities	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

Recruitment & Eligibility