Clinical trial NCT01757717: Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic or Recurrent Lesions in the Spine
Metastatic or Recurrent Lesions in the Pelvis
Keywords: radiation therapy
HDR brachytherapy
Ir-192 high dose rate
12-260
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-12-31
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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 \< 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

Primary outcomes:
measure: Maximum Radiation Dose
timeFrame: 1 year
Secondary outcomes:
measure: Number of Grade 3 of Higher Toxicities
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Yoshiya Yamada, MD
role: PRINCIPAL_INVESTIGATOR
References: