NCT05709782 Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC
| NCT ID | NCT05709782 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Spinal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-05-09 |
| Primary Completion | 2029-01-13 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2023-05-09 with a primary completion date of 2029-01-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To learn whether giving spinal stereotactic radiosurgery (SRSS) that uses a more advanced imaging scan method called Magnetic Resonance imaging with a Linear Accelerator (MR-LINAC) during treatment will lead to improved responses to treatment and better quality of life. SRSS is radiation therapy given to the area around your spine.
Eligibility Criteria
INCLUSION CRITERIA: 1. Age ≥ 18 years old 2. Radiographically documented disease of the spine within 4 weeks of registration (candidates with or without epidural disease allowed) 3. Candidate for spine SRS/SBRT as determined by treating Radiation Oncologist or Multidisciplinary Spine Conference review 4. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed 5. Diagnosis of cancer documented 6. Motor strength ≥ 4 out of 5 in the extremity affected by the level of spinal disease planned for radiation 7. Karnofsky Performance score (KPS) ≥ 40 or ECOG score ≤ 3 EXCLUSION CRITERIA: 1. Patients with highly radiosensitive histologies likely to respond to conventional radiation therapy alone (ie lymphoma, multiple myeloma, etc) 2. Patients who are unable to undergo MRI of the spine with contrast 3. Patients who are pregnant
Contact & Investigator
Debra N. Yeboa, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT05709782 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05709782 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05709782 currently recruiting?
Yes, NCT05709782 is actively recruiting participants. Contact the research team at dnyeboa@mdanderson.org for enrollment information.
Where is the NCT05709782 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05709782 clinical trial?
NCT05709782 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Debra N. Yeboa, MD at M.D. Anderson Cancer Center. The trial plans to enroll 40 participants.