MelanomaNCT02527304
Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery
A study testing Image-Guided Adaptive Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Melanoma and Metastatic Malignant Neoplasm in the Spine, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Metastatic Malignant Neoplasm in the Spine, Renal Cell Carcinoma
- What is being tested?
- Image-Guided Adaptive Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Melanoma, Metastatic Malignant Neoplasm in the Spine, Renal Cell Carcinoma, Soft Tissue Sarcoma, Spinal Cord Compression
- Being tested
- Image-Guided Adaptive Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration, Stereotactic Body Radiation Therapy
- Medical subject headings
- Melanoma, Carcinoma, Renal Cell, Sarcoma, Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-Guided Adaptive Radiation TherapyRadiation
Also called IGART
Undergo adaptive staged SBRT
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Stereotactic Body Radiation TherapyRadiation
Also called SBRT
Undergo adaptive staged SBRT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Image-Guided Adaptive Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 10 weeks after first treatment
Secondary outcomes (7)
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.
Measured: 10 weeks after first treatment
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.
Measured: Up to 10 weeks after first treatment
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.
Measured: 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
Data will be reported in a descriptive manner to describe any incidence of greater than or equal to 3 treatment related toxicity
Measured: Up to 2 years
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
Measured: Up to 2 years
Overall Survival
Data will be reported in a descriptive manner.
Measured: From study registration to death, censored at the date of data collection, assessed up to 2 years
Progression-free Survival
Data will be reported in a descriptive manner.
Measured: From study registration to date of disease progression or death, censored at the date of data collection, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Madhur Garg, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527304
- Sponsor's protocol ID
- 2015-4957
- Other IDs
- NCI-2015-01222, 007683, 2015-4957, P30CA013330
- Status last verified
- Feb 2024
- First submitted
- 17 Aug 2015
- Last updated
- 6 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery
- ClinicalTrials.gov ID
- NCT02527304
- Acronym / sponsor ID
- 2015-4957
- Conditions
- Melanoma, Metastatic Malignant Neoplasm in the Spine, Renal Cell Carcinoma, Soft Tissue Sarcoma, Spinal Cord Compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Posted 6 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (adaptive staged SBRT) | Experimental | Radiation: Image-Guided Adaptive Radiation Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Stereotactic Body Radiation TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image-Guided Adaptive Radiation TherapyAlso: IGARTUndergo adaptive staged SBRT | Radiation | Treatment (adaptive staged SBRT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (adaptive staged SBRT) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (adaptive staged SBRT) |
| Stereotactic Body Radiation TherapyAlso: SBRTUndergo adaptive staged SBRT | Radiation | Treatment (adaptive staged SBRT) |
Primary outcome
Distance Between the Gross Disease and Spinal Cord (Cord-disease Distance, CDD) of at Least 3mm After Treatment.
Time frame: Up to 10 weeks after first 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.
Number of Participants Demonstrating Successful Radiographic Response of the Spinal Tumor
Time frame: Up to 10 weeks after first treatment
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.
7 secondary outcomes
Change in Ambulation (Mobility)
Time frame: 10 weeks after first treatment
Change in Pain Control in Terms of Pain Scores as Measured by the Numeric Pain Rating Scale (NPRS) Estimation
Time frame: Up to 10 weeks after first treatment
Health Related Quality of Life Scores (FACT-G)
Time frame: 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
Time frame: Up to 2 years
Incidence of Grade Greater Than or Equal to 2 Radiation-induced Lung Toxicity (CTCAE), Version (v.) 4
Time frame: Up to 2 years
Overall Survival
Time frame: From study registration to death, censored at the date of data collection, assessed up to 2 years
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhur Garg principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image-Guided Adaptive Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Melanoma and Metastatic Malignant Neoplasm in the Spine, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance Between the Gross Disease and Spinal Cord (Cord-disease Distance, CDD) of at Least 3mm After Treatment. (time frame: Up to 10 weeks after first treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.