Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis
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ClinicalTrials.gov Identifier: NCT01757717 |
Recruitment Status
:
Completed
First Posted
: December 31, 2012
Results First Posted
: March 20, 2018
Last Update Posted
: March 20, 2018
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Tracking Information | ||||
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First Submitted Date ICMJE | December 19, 2012 | |||
First Posted Date ICMJE | December 31, 2012 | |||
Results First Submitted Date | January 23, 2018 | |||
Results First Posted Date | March 20, 2018 | |||
Last Update Posted Date | March 20, 2018 | |||
Study Start Date ICMJE | January 2013 | |||
Actual Primary Completion Date | July 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Maximum Radiation Dose [ Time Frame: 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
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Original Primary Outcome Measures ICMJE |
feasibility of High Dose Rate (HDR) treatment [ Time Frame: 1 year ] 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. |
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Change History | Complete list of historical versions of study NCT01757717 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Number of Grade 3 of Higher Toxicities [ Time Frame: 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
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Original Secondary Outcome Measures ICMJE |
Toxicity of HDR brachytherapy [ Time Frame: 1 year ] 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
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | 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 ICMJE | 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 | |||
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. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE |
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Intervention ICMJE | 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. |
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Study Arms | 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 and/or pelvis that have been maximally treated with external beam radiation therapy.
Intervention: Radiation: Ir-192 high dose rate (HDR) |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
3 | |||
Original Estimated Enrollment ICMJE |
20 | |||
Actual Study Completion Date | July 2017 | |||
Actual Primary Completion Date | July 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01757717 | |||
Other Study ID Numbers ICMJE | 12-260 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Memorial Sloan Kettering Cancer Center | |||
Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Memorial Sloan Kettering Cancer Center | |||
Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |