Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 16 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging

Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 21 Gray

Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 18 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging

Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 20 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging

Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 24 Gray

Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 27 Gray

prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment

questionnaire administration

prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy

diffusion tensor imaging

prior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafter

functional magnetic resonance imaging

two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy

hypo-fractionated SRS

two to three consecutive daily sessions within one week for 3 cohorts- for 3 cohorts- Cohort 1 = 16 Gy; Cohort 2 = 18 Gy; Cohort 3 = 20 Gy

single-fraction SRS

Minh-Tam Truong, MD

RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with spinal metastases.

OBJECTIVES:

* To implement CyberKnife® technology for improving palliation in patients with spinal metastases.
* To determine the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in these patients.
* To evaluate functional and diffusion MRI parameters in the spinal cord and tumor after treatment with Cyberknife® radiosurgery.

OUTLINE: Patients undergo placement of gold fiducial markers at the time of open surgical resection or percutaneous needle biopsy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 30-90 minutes daily for 2-3 days.

Patients undergo functional MRI and diffusion tensor imaging at baseline and then at 6 weeks and 6 months after completion of treatment. Patients also complete a pain questionnaire at baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment.

After completion of study treatment, patients are followed periodically for up to 2 years.

This is a Phase I study with 2 parallel groups of dose escalation using a 3 +3 design to determine the maximum tolerated dose of the radiation with the FDA approved device. There are three dose cohorts in each group, thus 6 arms.

Stereotactic Radiosurgery in Treating Patients With Spinal Metastases

Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine

There is no plan to share individual participant data.

Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery

Pain as measured by the Brief Pain Inventory and Roland scale

Spinal cord response as measured by functional MRI

United States Department of Defense

Boston Medical Center

BMC Attending Physician

Nervous System Diseases

Musculoskeletal Diseases

Recurrence

Spinal Cord Neoplasms

Spinal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Spinal Cord Diseases

Central Nervous System Diseases

Patients undergo posterior spinal tumor resection on day 0.

Patients undergo anterior and posterior tumor resection on day 0.

therapeutic conventional surgery

Undergo anterior and posterior spinal tumor resection

quality-of-life assessment

Rahul Jandial, MD

This randomized clinical trial studies minimally invasive surgery in treating patients with spinal tumors. Posterior spinal tumor resection and anterior and posterior spinal tumor resection are less invasive types of surgery for spinal tumors and may have fewer side effects and improve recovery

PRIMARY OBJECTIVES:

I. Length of operation (operating room \[OR\] time). II. Estimated blood loss (EBL). III. Complication rate. IV. Neurological preservation.

SECONDARY OBJECTIVES:

I. Motor strength and sensory level (neurological outcome). II. Bladder and bowel function. III. Post-operative pain. IV. Hospital length of stay (recovery time). V. Arthrodesis.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo posterior spinal tumor resection on day 0.

ARM II: Patients undergo anterior and posterior spinal tumor resection on day 0.

After completion of study treatment, patients are followed up for 6 months.

Minimally Invasive Surgery in Treating Patients With Spinal Tumors

Comparison of Minimally Invasive Approaches of Spine Tumor Surgery

Will be comparing means with the Wilcoxon test.

This is an assessment of sensory and motor functions based upon the ASIA Impairment Scale

Plain x-ray films and CT scans are used to determine the success of arthrodesis (spinal fusion in this case) which is the artificial induction of joint ossification between two bones via surgery. This is done to relieve intractable pain in a joint which cannot be managed by pain medication.

National Cancer Institute (NCI)

City of Hope Medical Center

Pain

Intervention:

This study is one arm. All patients will undergo radiotherapy followed by vertebroplasty. Patients who had prior radiotherapy will undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each. Patients has no prior radiotherapy will undergo 1 fraction of SBRT over 30-90 minutes. The full patient population will then undergo vertebroplasty\*.

\*Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up.

radiation

Robert D. Timmerman, MD

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Vertebroplasty may help prevent fractures and spinal cord compression caused by spinal metastasis. Giving stereotactic body radiation therapy together with vertebroplasty may help lessen pain and improve quality of life of patients with spinal metastasis.

PURPOSE: This phase II trial is studying how well giving stereotactic body radiation therapy together with vertebroplasty works in treating patients with localized spinal metastasis.

OBJECTIVES:

Primary

* To determine the efficacy of stereotactic body radiotherapy in reducing pain at 3 months in patients with localized spinal metastasis.

Secondary

* To determine the duration of pain response at the treated site(s) scored as the time of maximal pain relief to an increase of 2 points on the Visual Analogue Scoring System.
* To determine the functional preservation of improvement as measured by the Brief Pain Inventory.
* To prospectively assess quality of life using the FACT-G and EQ-5D questionnaires.
* To determine the long-term stability of the treated vertebral bone (e.g., fracture, sclerotic change, vertebral body height, or malalignment) as measured by MRI, CT scan, and plain radiographs.

OUTLINE: Patients are assigned to 1 of 2 treatment groups according to prior radiotherapy to the planned treatment site(s).

* Group 1 (prior radiotherapy): Patients undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each.
* Group 2 (no prior radiotherapy): Patients undergo 1 fraction of SBRT over 30-90 minutes.

Within 1 month after the initiation of SBRT, patients in both groups undergo percutaneous vertebroplasty.

Patients complete pain and quality-of-life questionnaires at baseline and periodically during study. Patients also undergo MRI and CT scan at baseline, at 1, 3, and 6 months, and then every 6 months for 3 years to assess changes in vertebral bone strength and stability.

After completion of study therapy, patients are followed at 2 weeks, at 1, 3, and 6 months, and then every 6 months for 3 years.

Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis

Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)

Pain reduction as measured by Visual Analogue Scoring System (VAS) at 3 months

Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response:

A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response

Duration of pain response as measured by VAS at 1 month

Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response:

A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response

Overall survival measured from the date of accession to the date of death. Median times will be reported.

Time to functional decline as measure by the Brief Pain Inventory (BPI) at baseline. BPI has two sections that are scored- pain severity and pain interference. For each of these a numeric scale from 0-10 is used, with 0 being the worst pain and 10 being the worst pain.

Number of participants who filled out the Functional Assessment of Cancer Therapy- General (FACT-G) and the European Quality of Life Five Dimension (EQ-5D) questionnaires at baseline, 1, 3, 6, and 12 months

University of Texas Southwestern Medical Center

Professor

Total Population

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Lung

Breast

Prostate

Kidney

Melanoma

Colorectal

Oropharyngeal

Thyroid

35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Radiosurgery in Treating Patients With Spinal Metastases	NCT00853528	Metastatic Canc...	questionnaire a... diffusion tenso... functional magn... hypo-fractionat... single-fraction...	18 Years -	Boston Medical Center
Stereotactic Radiosurgery in Treating Patients With Spinal Metastases	NCT00853528	Metastatic Canc...	questionnaire a... diffusion tenso... functional magn... hypo-fractionat... single-fraction...	18 Years -	Boston Medical Center
Minimally Invasive Surgery in Treating Patients With Spinal Tumors	NCT01308489	Adult Spinal Co... Recurrent Adult... Spinal Bone Met... Spinal Cord Met...	therapeutic con... therapeutic con... quality-of-life...	18 Years -	City of Hope Medical Center
Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis	NCT00855803	Metastatic Canc... Pain Unspecified Adu...	radiation	18 Years -	University of Texas Southwestern Medical Center
Minimally Invasive Surgery in Treating Patients With Spinal Tumors	NCT01308489	Adult Spinal Co... Recurrent Adult... Spinal Bone Met... Spinal Cord Met...	therapeutic con... therapeutic con... quality-of-life...	18 Years -	City of Hope Medical Center
Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis	NCT00855803	Metastatic Canc... Pain Unspecified Adu...	radiation	18 Years -	University of Texas Southwestern Medical Center

Spots Global Cancer Trial Database for spinal cord metastases