An interventional study of SBRT for Benign Extradural Spine Tumors and SBRT for Vertebral/Paraspinal Metastases in Spinal Metastases, Vertebral Metastases and Benign Spinal Tumors, sponsored by Mercy Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-18.
Sponsored by Mercy Research · Not applicable, Interventional, and Treatment
Among 44 studies in Chordoma with a site in United States — 7 open to participants now, 18 under way, none of them phase 3. Chordoma · United States.
Among the 44 studies in Chordoma with a site in United States, this one is the 11th largest by enrollment of the 32 interventional ones, is one of 2 that started in 2008, is one of 4 with no phase, and was the 13th registered.
68 studies on the registry are indexed under Chordoma; 15 are open to participants now.
This study's enrollment of 38 is close to the median of 38 across 50 interventional studies indexed under Chordoma.
Browse Chordoma studies →7 of the 44 studies in Chordoma with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 12 Chordoma studies recruiting now, 9 (75%) set no upper age limit and 1 (8%) stop at 75 or younger; 3 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →44 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 2 started in 2008.
Median enrollment 29 across the 32 interventional studies, 150 across the 11 observational. Of the 24 that completed or were terminated, 8 (33%) have results posted.
8 of 44 have an industry lead sponsor. The 10 most frequent:
Mercy Research is the lead sponsor of 17 studies on the registry; none are open to participants now.
Mercy Research has 1 study filed under Chordoma — fewer than ten, so there is no comparison to draw.
6 of the studies in Chordoma with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06794645Saint John's Cancer InstitutePembrolizumab and Pemetrexed for Progressive Chordoma | 2026-11-30 |
| NCT04087902Ohio State UniversityLong-Term Longitudinal QoL in Patients Undergoing EEA | 2026-12-31 |
| NCT05407441Susan Chi, MDTazemetostat+Nivo/Ipi in INI1-Neg/SMARCA4-Def Tumors | 2027-02-01 |
| NCT06957327Memorial Sloan Kettering Cancer CenterA Study of ERAS-601 in People With Chordoma | 2027-04 |
| NCT01346124Massachusetts General HospitalHigh Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull | 2027-06-30 |
Among the 44 studies in Chordoma with a site in United States, from their registry updates:
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine tumors.
This study is a single site, non-randomized, prospective, phase IV trial. Patients are composed of 2 groups:Spine Metastases OR Benign Spine Tumors. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.
Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years
Eligibility Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
Radiation: SBRT for Benign Extradural Spine Tumors
Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
Radiation: SBRT for Vertebral/Paraspinal Metastases
14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
Also known as: Stereotactic Body Radiotherapy (SBRT)
12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
Also known as: Stereotactic Body Radiotherapy (SBRT)
Initial Symptom Control
Evaluation of pain relief per patient report
Time frame: 6 weeks post-SBRT (or at first post-treatment follow-up)
Local Tumor Recurrence Rate
Local recurrence is defined as tumor recurrence or progression within the planning target volume. Local control rate will be evaluated by imaging techniques and/or clinical symptoms (worsening or no improvement in pain or neurologic compromise). If follow-up imaging is available, a local recurrence will be defined as an increase of \> 20% in tumor size.
Time frame: (1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death
Late Toxicity Rate
Toxicity will be assessed using CTCAE grading criteria at specified timepoints.
Time frame: at patient's last follow-up (at least 3 months from treatment) or time of death
| Milestone | SBRT for Benign Extradural Spine Tumors | SBRT for Vertebral/Paraspinal Metastases |
|---|---|---|
| Started | 3 | 33 |
| Completed | 3 | 28 |
| Not completed | 0 | 5 |
| Withdrew: Death | 0 | 4 |
| Withdrew: Physician decision | 0 | 1 |
Evaluation of pain relief per patient report
| Participants | SBRT for Benign Extradural Spine Tumors | SBRT for Vertebral/Paraspinal Metastases |
|---|---|---|
| Number with Follow-up Data | 3 | 28 |
| Number with Initial Symptom Control | 3 | 27 |
| Number without Symptom Control | 0 | 1 |
Local recurrence is defined as tumor recurrence or progression within the planning target volume. Local control rate will be evaluated by imaging techniques and/or clinical symptoms (worsening or no improvement in pain or neurologic compromise). If follow-up imaging is available, a local recurrence will be defined as an increase of \> 20% in tumor size.
| Participants | SBRT for Benign Extradural Spine Tumors | SBRT for Vertebral/Paraspinal Metastases |
|---|---|---|
| Local Control at last Follow-up | 3 | 25 |
| No Response to Treatment | 0 | 1 |
| Local Recurrence after Initial Response | 0 | 2 |
| Number with at least 1 year Follow-up | 3 | 18 |
| Local Control at 1 year Follow-up | 3 | 17 |
| Local Recurrence within 1st year of Follow-up | 0 | 1 |
Toxicity will be assessed using CTCAE grading criteria at specified timepoints.
| participants | SBRT for Benign Extradural Spine Tumors | SBRT for Vertebral/Paraspinal Metastases |
|---|---|---|
| Late Toxicity Rate | 0 | 0 |
Collected over Patients were followed until time of death or until lost to follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SBRT for Benign Extradural Spine Tumors | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| SBRT for Vertebral/Paraspinal Metastases | 27/28 (96.4%) | 1/28 (3.6%) | 7/28 (25%) |
| Event | SBRT for Benign Extradural Spine Tumors | SBRT for Vertebral/Paraspinal Metastases |
|---|---|---|
| EsophagitisGastrointestinal disorders | 0/3 | 1/28 |
| Event | SBRT for Benign Extradural Spine Tumors | SBRT for Vertebral/Paraspinal Metastases |
|---|---|---|
| Self limiting nauseaGastrointestinal disorders | 1/3 | 3/28 |
| mild esophagitisGastrointestinal disorders | 0/3 | 2/28 |
| desquamationSkin and subcutaneous tissue disorders | 0/3 | 1/28 |
| muscle painMusculoskeletal and connective tissue disorders | 0/3 | 1/28 |
2 enrolled patients were not treated. 35 patients completed 36 Stereotactic Body Radiotherapy courses for a total of 38 patients included at baseline.
| Age, Categorical(Participants) | SBRT for Benign Extradural Spine Tumors | SBRT for Vertebral/Paraspinal Metastases | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 20 | 22 |
| >=65 years | 1 | 15 | 16 |
| Age, Continuous(years) | SBRT for Benign Extradural Spine Tumors | SBRT for Vertebral/Paraspinal Metastases | Total |
|---|---|---|---|
| Age Range | 64 (55 to 82) | 62 (34 to 90) | 62 (34 to 90) |
| Sex: Female, Male(Participants) | SBRT for Benign Extradural Spine Tumors | SBRT for Vertebral/Paraspinal Metastases | Total |
|---|---|---|---|
| Female | 2 | 20 | 22 |
| Male | 1 | 15 | 16 |
| Race/Ethnicity, Customized(Participants) | SBRT for Benign Extradural Spine Tumors | SBRT for Vertebral/Paraspinal Metastases | Total |
|---|---|---|---|
| Race — Caucasion | 3 | 32 | 35 |
| Race — African American | 0 | 3 | 3 |
| Race — Other | 0 | 0 | 0 |
| Region of Enrollment(Participants) | SBRT for Benign Extradural Spine Tumors | SBRT for Vertebral/Paraspinal Metastases | Total |
|---|---|---|---|
| United States | 3 | 35 | 38 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2008 to primary completion in Sep 2017, 108 months.
Results were first posted in Jun 2020, 2 years 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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