Trial record 2 of 5 for:    12133

Radiotherapy for Solid Tumor Spine Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01752036
First received: December 14, 2012
Last updated: July 15, 2014
Last verified: July 2014

December 14, 2012
July 15, 2014
March 2013
February 2016   (final data collection date for primary outcome measure)
Rate of recurrence at 12 months [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01752036 on ClinicalTrials.gov Archive Site
  • Time to local recurrence [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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
Same as current
Not Provided
Not Provided
 
Radiotherapy for Solid Tumor Spine Metastases
Phase II Study of Post-Operative Stereotactic Radiosurgery for Solid Tumor Spine Metastases

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumor Spine Metastases
Radiation: Stereotactic Radiotherapy (SRS)
600 cGy x 5 fractions
Experimental: Stereotactic Radiotherapy (SRS)
Stereotactic radiosurgery (SRS) 600 cGy x 5 fractions
Intervention: Radiation: Stereotactic Radiotherapy (SRS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
Not Provided
February 2016   (final data collection date for primary outcome measure)

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.
Both
12 Years and older
No
Contact: Kristin Redmond, M.D. 410-614-1642 kjanson3@jhmi.edu
Contact: Kelly Szajna, R.N. 410-502-9242 kszajna1@jhmi.edu
United States
 
NCT01752036
J12133, NA_00080433
Yes
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Not Provided
Principal Investigator: Kristin Redmond, M.D. Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP