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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Metastatic or Recurrent Lesions in the Spine

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Trial Information

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


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 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

feasibility of High Dose Rate (HDR) treatment

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Yoshiya Yamada, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-260

NCT ID:

NCT01757717

Start Date:

January 2013

Completion Date:

December 2016

Related Keywords:

  • Metastatic or Recurrent Lesions in the Spine
  • radiation therapy
  • HDR brachytherapy
  • Ir-192 high dose rate
  • 12-260

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021