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Trial record 2 of 6 for:    12133

Radiotherapy for Solid Tumor Spine Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01752036
First Posted: December 18, 2012
Last Update Posted: October 6, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
  Purpose
Although it is being increasingly used off protocol, there is minimal data regarding the efficacy of stereotactic radiosurgery to the tumor bed following surgical resection of metastatic lesions to the spine. The primary objective of this study is to evaluate radiographic local recurrence in the tumor bed following stereotactic radiosurgery compared to the expected rate following conventional radiation therapy.

Condition Intervention Phase
Solid Tumor Spine Metastases Radiation: Stereotactic Radiotherapy (SRS) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Post-Operative Stereotactic Radiosurgery for Solid Tumor Spine Metastases

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Rate of recurrence at 12 months [ Time Frame: 1 year ]
    To estimate the rate of radiographic local recurrence at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.


Secondary Outcome Measures:
  • Time to local recurrence [ Time Frame: 1 year ]
    1.2.1 To estimate the time to radiographic local recurrence in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases

  • Rate of re-treatment [ Time Frame: 1 year ]
    1.2.2 To estimate the rate of re-treatment at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases

  • Rate of symptomatic recurrence [ Time Frame: 1 year ]
    1.2.3 To estimate the rate of symptomatic local recurrence at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases

  • Rate of radiation myelopathy [ Time Frame: 1 year ]
    1.2.4 To estimate the rate of radiation myelopathy in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases

  • Rate of wound dehiscence [ Time Frame: 1 year ]
    To estimate the rate of wound dehiscence in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases

  • Rate of time to return to chemotherapy [ Time Frame: 1 year ]
    To estimate the time to return to chemotherapy in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases

  • Rate of local symptomatic recurrence [ Time Frame: 1 year ]
    To evaluate whether symptomatic local recurrence rates vary with tumor histology in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases


Estimated Enrollment: 35
Study Start Date: March 2013
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Radiotherapy (SRS)
Stereotactic radiosurgery (SRS) 600 cGy x 5 fractions
Radiation: Stereotactic Radiotherapy (SRS)
600 cGy x 5 fractions

Detailed Description:
This is a phase II trial evaluating the rate radiographic local recurrence following post-operative stereotactic radiosurgery boost in patients with metastatic solid malignancies with spine metastases status post resection. Patients will be treated with 600 cGy x 5 fractions to the tumor bed and then followed both clinically and radiographically to determine if local recurrence following this treatment is better than might be expected for conventional radiation therapy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥12 years
  • Histologically proven solid tumor malignancy with metastasis to the spine. Diagnosis may be acquired from needle biopsy, cytology, or surgical biopsy or resection.
  • Radiographic evidence of spinal metastasis is required and may be obtained from plain radiographs, radionuclide bone scans, computed tomography imaging, and magnetic resonance imaging. Other studies may be used with principal investigator approval.
  • The patient must have undergone surgical resection resection (gross total, subtotal, or biopsy) of the spinal lesion(s) no more than 12 weeks prior to SRS treatment.
  • Treating physician must deem that SRS is appropriate treatment for the metastatic spinal lesion(s).
  • Each SRS target must be the equivalent of ≤3 vertebral levels
  • The patient must have a Karnofsky Performance Score of 40 or greater
  • If a woman is of child-bearing potential, a negative urine or serum pregnancy test must be demonstrated prior to treatment. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and for up to 12 weeks following the study. Should a woman become pregnant or suspect she is pregnant while participating in this study she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Prior radiation or radiosurgery to the involved level of the spine
  • Spine disease from leukemia, lymphoma or myeloma
  • No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancer from which the patient has been disease free for at least 1 year.
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements will be excluded.
  • Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use and acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded. Male subjects must also agree to use effective contraception for the same period as above.
  Contacts and Locations
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): NCT01752036


Locations
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Kristin Redmond, M.D. Johns Hopkins University
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01752036     History of Changes
Other Study ID Numbers: J12133
NA_00080433 ( Other Identifier: JHMIRB )
First Submitted: December 14, 2012
First Posted: December 18, 2012
Last Update Posted: October 6, 2017
Last Verified: October 2017

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
stereotactic radiotherapy
SRS

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes