Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine
This study is currently recruiting participants.
Verified April 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01757717
First received: December 19, 2012
Last updated: April 11, 2013
Last verified: April 2013
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Purpose
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 the radiation to the spinal tumor that you need and decrease the amount of radiation delivered to the spinal cord.
| Condition | Intervention |
|---|---|
|
Metastatic or Recurrent Lesions in the Spine |
Radiation: Ir-192 high dose rate (HDR) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| 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 |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- feasibility of High Dose Rate (HDR) treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
of spine lesions using catheters placed under imageguided navigational techniques, to provide improved dosimetric coverage of spinal lesions such that.
In terms of technical feasibility, a patient is regarded as being successfully treated if the target D90 is ≥ 80% AND the cord/cauda max dose is 8 Gy.
Secondary Outcome Measures:
- Toxicity of HDR brachytherapy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]for previously irradiated lesions of the spine, 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
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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 that have been maximally treated with external beam radiation therapy.
|
Radiation: Ir-192 high dose rate (HDR)
Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 equina 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 exceeds 100 Gy in 2 Gy BED equivalents, the patient will be potentially eligible, where a total of 100 Gy in 2 Gy equivalents is determined by the biological equivalent dose (BED) calculation; BED(2Gy equivalents) = 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 symptomatic compression fractures that will require kyphoplasty cement or surgical fixation.
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757717
Contacts
| Contact: Yoshiya Yamada, MD | 212-639-2950 | |
| Contact: Mark Bilsky, MD | 212-639-8526 |
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Yoshiya Yamada, MD 212-639-2950 | |
| Contact: Mark Bilsky, MD 212-639-8526 | |
| Principal Investigator: Yoshiya Yamada, MD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Yoshiya Yamada, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01757717 History of Changes |
| Other Study ID Numbers: | 12-260 |
| Study First Received: | December 19, 2012 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
radiation therapy HDR brachytherapy Ir-192 high dose rate 12-260 |
ClinicalTrials.gov processed this record on May 23, 2013