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Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT02527304
Recruitment Status : Unknown
Verified January 2016 by Madhur Garg, Albert Einstein College of Medicine.
Recruitment status was:  Recruiting
First Posted : August 19, 2015
Last Update Posted : January 13, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Madhur Garg, Albert Einstein College of Medicine

Brief Summary:
This pilot clinical trial studies adaptive staged stereotactic body radiation therapy (SBRT) in treating patients with spinal metastases that cannot be removed by surgery. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Adaptive SBRT uses information gathered during treatment to inform, guide, and alter future radiation treatments. Staged SBRT uses multiple treatments separated by 2-3 weeks. Giving adaptive staged SBRT may work better in treating spinal metastases that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Melanoma Metastatic Malignant Neoplasm in the Spine Renal Cell Carcinoma Soft Tissue Sarcoma Spinal Cord Compression Radiation: Image-Guided Adaptive Radiation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Stereotactic Body Radiation Therapy Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the feasibility of single-fraction radiotherapy to provide a short-interval treatment response in patients with metastatic epidural spinal cord compression (MESCC), such that additional stereotactic radiotherapy to full therapeutic doses can be delivered while respecting spinal cord constraints, based on the following metrics: shortest distance between gross disease and the spinal cord before and after treatment; epidural tumor volume before and after treatment; and extent of epidural compression before and after treatment.

SECONDARY OBJECTIVES:

I. To evaluate pain control using the Numerical Rating Pain Scale (NRPS) before and after treatment.

II. To evaluate patient quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G) before and after treatment.

III. To evaluate functional outcomes using ambulation score and standardized neurologic exams before and after treatment.

OUTLINE:

Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints.

After completion of study treatment, patients are followed up periodically.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adaptive Staged SBRT for Spinal Metastases
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (adaptive staged SBRT)
Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints.
Radiation: Image-Guided Adaptive Radiation Therapy
Undergo adaptive staged SBRT
Other Name: IGART

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Stereotactic Body Radiation Therapy
Undergo adaptive staged SBRT
Other Name: SBRT




Primary Outcome Measures :
  1. Radiographic response of the spinal tumor, as measured by a reduction in the epidural tumor volume >= 10% after treatment on imaging scans (MRI or CT myelogram) [ Time Frame: Up to 10 weeks after first treatment ]
    Data will be summarized using standard descriptive statistics; formal hypothesis testing will not be performed. Confidence intervals for the true proportion will be computed using Clopper-Pearson exact confidence interval. The width shows that the response rate will not be lower than 20%. Since this is a feasibility, study no power calculation is done.

  2. Radiographic response of the spinal tumor, as measured by a reduction in thecal sac compression by >= 10% after treatment on imaging scans (MRI or CT myelogram) [ Time Frame: Up to 10 weeks after first treatment ]
    Data will be summarized using standard descriptive statistics; formal hypothesis testing will not be performed. Confidence intervals for the true proportion will be computed using Clopper-Pearson exact confidence interval. The width shows that the response rate will not be lower than 20%. Since this is a feasibility, study no power calculation is done.

  3. Radiographic response of the spinal tumor, as measured by distance between the gross disease and spinal cord >= 3 mm after treatment on imaging scans (MRI or CT myelogram) [ Time Frame: Up to 10 weeks after first treatment ]
    Data will be summarized using standard descriptive statistics; formal hypothesis testing will not be performed. Confidence intervals for the true proportion will be computed using Clopper-Pearson exact confidence interval. The width shows that the response rate will not be lower than 20%. Since this is a feasibility, study no power calculation is done.


Secondary Outcome Measures :
  1. Change in ambulation based on ambulation score and standardized neurologic exam [ Time Frame: Baseline to week 10 after first treatment ]
    Data will be reported in a descriptive manner.

  2. Change in pain control in terms of pain scores as measured by the NRPS estimation [ Time Frame: Baseline to week 10 after first treatment ]
    Data will be reported in a descriptive manner.

  3. Change in quality of life scores from FACT-G [ Time Frame: Baseline to up to 3 months ]
    Data will be reported in a descriptive manner.

  4. Incidence of any grade >= 3 treatment-related toxicity, scored using CTCAE, v. 4 [ Time Frame: Up to 2 years ]
    Data will be reported in a descriptive manner.

  5. Incidence of grade >= 2 radiation-induced lung toxicity, scored using Common Toxicity Criteria for Adverse Events (CTCAE), version (v.) 4 [ Time Frame: Up to 2 years ]
    Data will be reported in a descriptive manner.

  6. Overall survival [ Time Frame: From study registration to death, censored at the date of data collection, assessed up to 2 years ]
    Data will be reported in a descriptive manner.

  7. Progression-free survival [ Time Frame: From study registration to date of disease progression or death, censored at the date of data collection, assessed up to 2 years ]
    Data will be reported in a descriptive manner.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Localized spine metastasis from the cervical (C)1 to lumbar (L)5 levels with documented epidural cord compression by a screening imaging study (magnetic resonance imaging [MRI] or computed tomography [CT] myelogram); site may have a maximal involvement of 2 contiguous vertebral bodies; patients with other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible
  • History/physical examination by the treating physician within 24 hours prior to registration
  • Neurological and functional examination within 24 hours prior to registration by the treating physician
  • Negative serum pregnancy test
  • MRI (contrast is not required but strongly recommended) or CT myelogram of the involved spine within 1 week prior to registration to determine the extent of the spine involvement
  • Numerical rating pain scale within 1 week prior to registration; documentation of the patient's initial pain score is required; patients taking medication for pain at the time of registration are eligible
  • Women of childbearing potential must:

    • Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
    • Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
    • Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
  • All patients must sign study specific informed consent prior to study entry or within 1 week of first treatment, provided other criteria were met
  • Patients considered for enrollment are strongly recommended to have been discussed at multidisciplinary tumor board with input from surgery, medical oncology and radiation oncology prior to enrollment

Exclusion Criteria:

  • Histologies of myeloma or lymphoma
  • Cord compression at 2 non-contiguous sites in the spine
  • Favorable candidates for surgical decompression by prior documented criteria
  • Spine instability as determined by Spinal Instability Neoplastic Score (SINS) score > 12
  • > 50% loss of vertebral body height
  • Bony retropulsion causing neurologic abnormality
  • Prior radiation to the index spine
  • Patients who cannot obtain a contrast-enhanced MRI or CT myelogram due to allergy, renal failure or other medical contraindication

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): NCT02527304


Locations
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United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Madhur K. Garg    718-920-4361    mgarg@montefiore.org   
Principal Investigator: Madhur K. Garg         
Sponsors and Collaborators
Albert Einstein College of Medicine
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Madhur Garg Albert Einstein College of Medicine

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Responsible Party: Madhur Garg, Principal Investigator, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02527304     History of Changes
Other Study ID Numbers: 2015-4957
NCI-2015-01222 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
007683
2015-4957 ( Other Identifier: Albert Einstein College of Medicine )
P30CA013330 ( U.S. NIH Grant/Contract )
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Sarcoma
Carcinoma, Renal Cell
Neoplasms
Neoplasms, Second Primary
Spinal Cord Compression
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Connective and Soft Tissue
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Injuries
Wounds and Injuries