N/A
N=41
A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
Spinal Tumor
Bottom Line
View on ClinicalTrials.gov: NCT01624220 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Overall Response at Protocol Treatment Site — 23; 2; 7; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spinal SBRT (Standard Dose) (Radiation); Spinal SBRT (Higher Dose) (Radiation); Gold Seed Implantation (Procedure); Questionnaires (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response at Protocol Treatment Site |
23; 2; 7; 0; 8; 1 | — |
Summary
The goal of the first part of this clinical research study is to learn how to deliver more accurate radiation treatment of tumors in the spine. Researchers also want to learn how internal organs might move during radiation treatment.
The goal of the second part of this study is to learn if it is safe to allow slightly more radiation to the normal esophagus when spinal tumors close by are being treated. This may result in better tumor control.
Eligibility Criteria
Inclusion Criteria
- STAGE 1: >/= 18 years old
- STAGE 1: Pathologically confirmed diagnosis of cancer, including, but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and carcinoma of unknown primary
- STAGE 1: Signed informed consent
- STAGE 2: 1-3 above, and Patients undergoing single fraction spinal SBRT
Exclusion Criteria
- STAGE 1: Patient with radiosensitive histologies (lymphoma, multiple myeloma, small cell carcinomas, germ cell tumors)
- STAGE 1: Extensive (> 50%) height loss of the involved vertebral body
- STAGE 1: Inability to tolerate lying flat on treatment table for greater than 30 minutes
- STAGE 1: Pregnancy
- STAGE 2: Prior irradiation of the spine site and level to be treated
- STAGE 2: Patients with primary disease arising in the posterior elements of the VB in question
- STAGE 2: History of Barrett's esophagus, esophageal webbing, stricture, or fistula
- STAGE 2: Prior radiation to the esophagus
Data sourced from ClinicalTrials.gov (NCT01624220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.