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

NCT02527304 | Completed Results DMC FDA Device

• 4 other identifiers: 2015-4957NCI-2015-01222007683P30CA013330
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Metastatic Malignant Neoplasm in the Spine; Renal Cell Carcinoma; Soft Tissue Sarcoma; Spinal Cord Compression

Outcome Measures

Primary Outcomes (2)

• Distance Between the Gross Disease and Spinal Cord (Cord-disease Distance, CDD) of at Least 3mm After Treatment.

  Cord-disease distance of at least 3mm in shortest axial distance after treatment. Data was summarized using standard descriptive statistics; formal hypothesis testing was not performed. Confidence intervals for the true proportion were computed using Clopper-Pearson exact confidence interval were not conducted. Since this was a feasibility, study no power calculation was done.

  Up to 10 weeks after first treatment

• Number of Participants Demonstrating Successful Radiographic Response of the Spinal Tumor

  Successful radiographic response of the spinal tumor was determined by achieving of a 10% reduction in epidural volume or thecal sac compression (i.e., \~10% absolute increase in thecal sac patency (TSP)) following treatment, on either of their MRI imaging or CT myelogram scans. Data was summarized using standard descriptive statistics; formal hypothesis testing was not performed. Confidence intervals for the true proportion using Clopper-Pearson exact confidence interval were not conducted. Since this is a feasibility study no power calculation was done.

  Up to 10 weeks after first treatment

Secondary Outcomes (7)

• Change in Ambulation (Mobility)

  10 weeks after first treatment

• Change in Pain Control in Terms of Pain Scores as Measured by the Numeric Pain Rating Scale (NPRS) Estimation

  Up to 10 weeks after first treatment

• Health Related Quality of Life Scores (FACT-G)

  Up to 3 months following first treatment

• Incidence of Any Grade Greater Than or Equal to 3 Treatment-related Toxicity, Scored Using CTCAE, v. 4

  Up to 2 years

• Incidence of Grade Greater Than or Equal to 2 Radiation-induced Lung Toxicity (CTCAE), Version (v.) 4

  Up to 2 years

Study Arms (1)

Treatment (adaptive staged SBRT)

EXPERIMENTAL

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; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

Interventions

Image-Guided Adaptive Radiation Therapy RADIATION

Undergo adaptive staged SBRT

Also known as: IGART

Treatment (adaptive staged SBRT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (adaptive staged SBRT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (adaptive staged SBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo adaptive staged SBRT

Also known as: SBRT

Treatment (adaptive staged SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Renal Cell; Sarcoma; Spinal Cord Compression

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplasms, Connective and Soft Tissue; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Madhur Garg, Clinical Director, Department of Radiation Oncology
• Organization: Montefiore Medical Center

mgarg@montefiore.org

718-920-4361

Study Officials

• Madhur Garg

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 19, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: March 6, 2024
• Results First Posted: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)