Clinical trial NCT02527304: Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery
Official title: Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Metastatic Malignant Neoplasm in the Spine
Renal Cell Carcinoma
Soft Tissue Sarcoma
Spinal Cord Compression
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-08-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Distance Between the Gross Disease and Spinal Cord (Cord-disease Distance, CDD) of at Least 3mm After Treatment.
timeFrame: Up to 10 weeks after first treatment
measure: Number of Participants Demonstrating Successful Radiographic Response of the Spinal Tumor
timeFrame: Up to 10 weeks after first treatment
Secondary outcomes:
measure: Change in Ambulation (Mobility)
timeFrame: 10 weeks after first treatment
measure: Change in Pain Control in Terms of Pain Scores as Measured by the Numeric Pain Rating Scale (NPRS) Estimation
timeFrame: Up to 10 weeks after first treatment
measure: Health Related Quality of Life Scores (FACT-G)
timeFrame: Up to 3 months following first treatment
measure: Incidence of Any Grade Greater Than or Equal to 3 Treatment-related Toxicity, Scored Using CTCAE, v. 4
timeFrame: Up to 2 years
measure: Incidence of Grade Greater Than or Equal to 2 Radiation-induced Lung Toxicity (CTCAE), Version (v.) 4
timeFrame: Up to 2 years
measure: Overall Survival
timeFrame: From study registration to death, censored at the date of data collection, assessed up to 2 years
measure: Progression-free Survival
timeFrame: From study registration to date of disease progression or death, censored at the date of data collection, assessed up to 2 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Madhur Garg
role: PRINCIPAL_INVESTIGATOR
References: