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. (see Contacts and Locations)

Verified December 2014 by Memorial Sloan Kettering Cancer Center.

Sponsor:

Information provided by (Responsible Party):

Memorial Sloan Kettering Cancer Center.

ClinicalTrials.gov Identifier:

NCT01757717

First received: December 19, 2012

Last updated: December 22, 2014

Last verified: December 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

December 19, 2012

Last Updated Date

December 22, 2014

Start Date ^ICMJE

January 2013

Estimated Primary Completion Date

December 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

feasibility of High Dose Rate (HDR) treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

of spine lesions using catheters placed under image guided 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.

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT01757717 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

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

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

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 the radiation to the spinal tumor that you need and decrease the amount of radiation delivered to the spinal cord.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Metastatic or Recurrent Lesions in the Spine

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.

Study Arm (s)

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.

Intervention: Radiation: Ir-192 high dose rate (HDR)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2017

Estimated Primary Completion Date

December 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yoshiya Yamada, MD	212-639-2950
Contact: Mark Bilsky, MD	212-639-8526

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

Responsible Party

Memorial Sloan Kettering Cancer Center.

Study Sponsor ^ICMJE

Memorial Sloan Kettering Cancer Center.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Yoshiya Yamada, MD

Memorial Sloan Kettering Cancer Center.

Information Provided By

Memorial Sloan Kettering Cancer Center.

Verification Date

December 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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