N/A
Completed N=3
Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis
Metastatic or Recurrent Lesions in the Spine · Metastatic or Recurrent Lesions in the Pelvis
Source: ClinicalTrials.gov NCT01757717 ↗
Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Maximum Radiation Dose — 7 cord/cauda max dose in Gy
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Radiation Dose |
7 | — |
| SECONDARY Number of Grade 3 of Higher Toxicities |
— | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01757717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.