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

Browse trials for

• Melanoma 3,370
• Carcinoma, Renal Cell 2,037
• Sarcoma 1,607
• Spinal Cord Compression 52

Melanoma

3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.

This study's enrollment of 24 is below the median of 40 across 2,649 interventional studies indexed under Melanoma.

Lead sponsor

Albert Einstein College of Medicine is the lead sponsor of 201 studies on the registry; 21 are open to participants now.

Of its 46 completed or terminated interventional studies of FDA-regulated products, 37 (80%) have results posted.

Study arms

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

Interventions

• RadiationImage-Guided Adaptive Radiation Therapy

  Undergo adaptive staged SBRT

  Also known as: IGART

• OtherQuality-of-Life Assessment

  Ancillary studies

  Also known as: Quality of Life Assessment

• OtherQuestionnaire Administration

  Ancillary studies

• RadiationStereotactic Body Radiation Therapy

  Undergo adaptive staged SBRT

  Also known as: SBRT

Primary outcomes

1. 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.

   Time frame: Up to 10 weeks after first treatment

2. 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.

   Time frame: Up to 10 weeks after first treatment

Secondary outcomes

1. Change in Ambulation (Mobility)

   Ambulation was assessed as a functional outcome by the treating physician. Scoring was adapted from the ICORG Phase III trial, ASTRO 2014. Mobility scores were assigned as follows: 1 = ambulatory without aid; 2 = ambulatory with aid; 3 = not ambulatory; and 4 = paraplegia. Basic descriptive statistics were used to assess changes in ambulation from baseline.

   Time frame: 10 weeks after first treatment

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

   Participants were asked to provide a numeric value using the NPRS to describe their pain intensity. The NPRS is a unidimensional assessment tool which measures pain on an 11-point (0-10) numeric scale where "0" represents no pain and "10" represents extreme pain. Higher scores are indicative of worsening pain intensity.

   Time frame: Up to 10 weeks after first treatment

3. Health Related Quality of Life Scores (FACT-G)

   Health-related Quality of Life was measured using Functional Assessment of Cancer Therapy - General (FACT-G) a 27-item questionnaire designed to measure four domains of Quality of Life in cancer patients assessed over the previous 7-day period: physical well-being (7 questions), social/family well-being (7 questions), emotional being (6 questions), and functional well-being (7 questions). Participant responses are assessed using a 5 point Likert-type scale ranging from 0 (Not at all) to 4 (Very much). A FACT-G total score is computed as the sum of the four subscale scores, provided the overall item response is at least 80% (i.e. at least 22 of the 27 items answered) and has a possible range of 0-108 points. Negatively worded items are reverse scored prior to summing so that higher subscale and total scores indicate a better overall health state corresponding Quality of Life.

   Time frame: Up to 3 months following first treatment

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

   Data will be reported in a descriptive manner to describe any incidence of greater than or equal to 3 treatment related toxicity

   Time frame: Up to 2 years

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

   Data will be reported in a descriptive manner to describe any incidence of grade 2 or greater related radiation induced lung toxicity

   Time frame: Up to 2 years

6. Overall Survival

   Data will be reported in a descriptive manner.

   Time frame: From study registration to death, censored at the date of data collection, assessed up to 2 years

7. Progression-free Survival

   Data will be reported in a descriptive manner.

   Time frame: From study registration to date of disease progression or death, censored at the date of data collection, assessed up to 2 years

Baseline characteristics

Study documents

• Protocol and statistical analysis plan ↗ · Dec 15, 2016

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No