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Radiotherapy for Solid Tumor Spine Metastases

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.
 
ClinicalTrials.gov Identifier: NCT01752036
Recruitment Status : Completed
First Posted : December 18, 2012
Results First Posted : June 25, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
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 or disease Intervention/treatment Phase
Solid Tumor Spine Metastases Radiation: Post-operative, Stereotactic Body Radiation Therapy (SBRT) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Post-Operative Stereotactic Radiosurgery
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Post-Operative Stereotactic Radiosurgery for Solid Tumor Spine Metastases
Actual Study Start Date : May 20, 2013
Actual Primary Completion Date : April 2, 2018
Actual Study Completion Date : July 27, 2018

Arm Intervention/treatment
Treatment
Post-Operative Stereotactic Radiosurgery
Radiation: Post-operative, Stereotactic Body Radiation Therapy (SBRT)
All participants received SBRT at 600 cGy x 5 fractions




Primary Outcome Measures :
  1. Number of Participants With Radiographic 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.

  2. Time to Local Recurrence [ Time Frame: 1 year ]
    To estimate the time (in months) to radiographic local recurrence in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.


Secondary Outcome Measures :
  1. Number of Participants Receiving Re-treatment [ Time Frame: 1 year ]
    To estimate the rate of re-treatment at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases

  2. Number of Participants With Symptomatic Recurrence [ Time Frame: 1 year ]
    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

  3. Number of Participants Experiencing Radiation Myelopathy [ Time Frame: 1 year ]
    Number of participants experiencing radiation myelopathy in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases

  4. Number of Participants Experiencing Wound Dehiscence [ Time Frame: 1 year ]
    Number of participants treated with a post-operative stereotactic radiosurgery boost for resected spine metastases, experiencing wound dehiscence.

  5. Time to Return to Chemotherapy [ Time Frame: 1 year ]
    Time in months to return to chemotherapy in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.

  6. Number of Participants With Radio-sensitive Tumors Who Had Symptomatic Local Recurrence [ Time Frame: 1 year ]
    To evaluate the post-treatment symptomatic local recurrence in patients with radio-sensitive tumors.



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Ages Eligible for Study:   12 Years to 100 Years   (Child, Adult, Older Adult)
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.

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
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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 at Johns Hopkins
Investigators
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Principal Investigator: Kristin Redmond, M.D. Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Publications of Results:
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01752036    
Other Study ID Numbers: J12133
NA_00080433 ( Other Identifier: JHMIRB )
First Posted: December 18, 2012    Key Record Dates
Results First Posted: June 25, 2020
Last Update Posted: June 25, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
stereotactic radiotherapy
SRS
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes