Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial for Salvage Re-Irradiation of Metastatic Spine Lesions Using Single-Fraction Stereotactic Radiosurgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278744
Recruitment Status : Recruiting
First Posted : October 30, 2014
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
This is a phase I clinical trial investigating the use of single fraction re-irradiation following local progression of spine and cauda equina (L2 to sacrum) lesions that have previously received radiation therapy. Patients will be treated with single-fraction radiation therapy at 3 dose levels using image-guided stereotactic radiosurgery techniques.

Condition or disease Intervention/treatment Phase
Metastatic Spine Lesions Radiation: single-fraction radiation Device: MRI and/or CT Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Trial for Salvage Re-Irradiation of Metastatic Spine Lesions Using Single-Fraction Stereotactic Radiosurgery
Study Start Date : October 2014
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: single-fraction radiosurgery Radiation: single-fraction radiation
Patients enrolled on this study will be registered into a dose tier and undergo 1 session of image-guided SRS using techniques previously. Three escalating SRS spinal cord/cauda maximum dose (Dmax) levels (14 Gy, 16 Gy, and 17 Gy) will be evaluated to determine the safety of this approach. A minimum of three patients will be treated per dose tier. Toxicity based on NCI CTCAE (v4). Post treatment followup at 2 and 4 months (+/- 2 weeks) post-treatment, at 6 months (+/- 4 weeks) and then every 3 months until 2 years (± 4 weeks). Followup schedule based on last day of treatment. No schedule adjustments based on early or delayed visits.
Other Name: stereotactic radiosurgery (SRS)

Device: MRI and/or CT



Primary Outcome Measures :
  1. toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria [ Time Frame: 1 year ]
    The toxicities associated with single fraction stereotactic radiosurgery to the spine may be classified as either early (occurring within 90 days of the treatment) or late toxicities (after 90 days to 1 year). These toxicities will be evaluated with the National Cancer Institute (NCI) Common Toxicity Criteria.


Secondary Outcome Measures :
  1. local failure [ Time Frame: 1 year ]
    tumor control will be defined for this study as the absence of tumor progression at the treated site, where progression may consist of an increase in maximal dimension of the tumor by ≥20%, compromise of the spinal cord/cauda equina and/or exiting spinal nerves (assessed clinically or radiographically), or both.

  2. overall survival [ Time Frame: 2 years ]
    will be evaluated from the completion of treatment, and analyzed by the Kaplan-Meier method or cumulative incidence curves. For these outcomes, patients across all dose levels will be combined, and will only be evaluated for a maximum of 2 years on protocol.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologic or cytologic proof of a non-hematologic malignancy confirmed by MSKCC pathologic review
  • Patients must have radiographic evidence of malignancy in the spine or cauda equina region (L2 to sacrum) which is suitable for radiation therapy
  • Patients must have received prior external beam radiation therapy to the region proposed for SRS re-irradiation at least 6 months prior to planned re-irradiation
  • For patients who were previously treated at an outside institution, adequate records must be available to determine the true dose the cord/cauda received during prior RT. Sufficiency of the treatment records will be assessed and signed-off by the Medical Physics investigator.
  • Patients must have demonstrated progression of disease on MRI or CT assessment of the spinal cord/cauda within the previous radiation field

    o progression may consist of an increase in maximal dimension of the tumor by ≥20%, compromise of the spinal cord/cauda equina and/or exiting spinal nerves (assessed clinically or radiographically), or both.

  • Target lesion size for re-irradiation must be ≤ 2 vertebral bodies
  • KPS ≥ 60%
  • Age ≥ 18 years old

Exclusion Criteria:

  • Patients with a life expectancy of < 6 months as predicted by the Adult Comorbidity Index (ACE-27, see Appendix 1).
  • Patients with intradural or intramedullary lesions, or lesions with < 2mm distance from tumor to spinal cord
  • Patients with circumferential epidural disease
  • Systemic chemotherapy delivered or planned to be delivered within (+/-) 5 days of SRS re-irradiation
  • Patients receiving bevacizumab within 12 weeks prior to protocol treatment.
  • Unable to undergo either a myelogram or MRI of spinal cord/cauda equina and/or exiting spinal nerves
  • Patients who may not receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by the Dose Limit Guidelines Evaluation of doses previously delivered to spinal cord/cauda equina and other critical structures (bowel, esophagus, kidneys, rectum) will be taken into consideration

    • If repeat irradiation would exceed any normal tissue constraint as noted in Appendix 2, the patient will be ineligible
    • If the total prior radiation dose to the spinal cord/cauda equina and/or sacrum over all prior treatments exceeds 100 Gy BED (biologically effective dose), the patient will be ineligible, where a total of 100 Gy BED is determined by the 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/cauda/sacrum late effect and equals 2 [Rades 2005, Nieder 2005, Sahgal 2012]
  • Patients with paraspinal extension of disease with visceral involvement exclusive of patients with cauda equina and sacral disease extension.
  • Abnormal complete blood count. Any of the following:

    • Platelet count < 75,K/mcL
    • Hemoglobin level < 9g/dl
    • WBC < 3.5K/mcL
  • Abnormal coagulation profile: INR > 2.5 and/or PTT > 80

    o 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

  • Pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278744


Contacts
Layout table for location contacts
Contact: Yoshiya Yamada, MD 212-639-2950
Contact: Mark Bilsky, MD 212-639-8526

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Yoshiya Yamada, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02278744    
Other Study ID Numbers: 14-054
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
Single-Fraction Stereotactic Radiosurgery
Salvage Re-Irradiation
14-054