Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic or Recurrent Lesions in the Spine; Metastatic or Recurrent Lesions in the Pelvis
• Intervention / Treatment: Radiation: Ir-192 high dose rate (HDR)

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Radiation Dose	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Grade 3 of Higher Toxicities	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	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Yoshiya Yamada, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: December 19, 2012
• First Submitted That Met QC Criteria: December 21, 2012
• First Posted (Estimate): December 31, 2012

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: radiation therapy; HDR brachytherapy; Ir-192 high dose rate; 12-260
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 12-260