Clinical trial · Interventional
A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
NCT01624220CI-TRIAL-00111235completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Spinal Tumor | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gold Seed Implantation | Procedure | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Spinal SBRT (Higher Dose) | Radiation | — | UNRESOLVED |
| Spinal SBRT (Standard Dose) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypofractionated Radiation
- description
- All patients receive CT-guided spinal SBRT using IMRT to maximize conformality of treatment plan to target volume, while sparing normal structures. Dose given to tumor and number of treatments received determined by patient's doctor. In second stage, characterize tolerance of esophagus to hypofractionated radiation doses through prospective constraint relaxation and toxicity monitoring. Data collected from Group 1 in first stage will give data on dose delivered to esophagus. Second stage of protocol will begin accrual once Group 1 has filled. Dose constraints used for Groups 3 allow higher dose. Dose constraints for Group 4 represent modest increase of esophageal dose maximums.
- interventionNames
- Radiation: Spinal SBRT (Higher Dose)
- Procedure: Gold Seed Implantation
- Behavioral: Questionnaires
- type
- EXPERIMENTAL
- label
- ExacTrac Positioning System
- description
- Analysis performed of ExacTrac positioning system with and without fiducial guidance. Four dimensional CT datasets for simulation will allow use of data from this portion of protocol to characterize degree to which organ at risk (OAR) motion is relevant at each spinal level. 20 patients accrued in two groups of 10, with 10 patients in each rostral-caudal position in the spine (Group 1: T4-T12, Group 2: L1-L5). Imaging done with fiducial markers for this study will not impact patient management. Patients will treated with standard dose constraints to normal tissues.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. STAGE 1: \>/= 18 years old 2. 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 3. STAGE 1: Signed informed consent 4. STAGE 2: 1-3 above, and Patients undergoing single fraction spinal SBRT Exclusion Criteria: 1. STAGE 1: Patient with radiosensitive histologies (lymphoma, multiple myeloma, small cell carcinomas, germ cell tumors) 2. STAGE 1: Extensive (\> 50%) height loss of the involved vertebral body 3. STAGE 1: Inability to tolerate lying flat on treatment table for greater than 30 minutes 4. STAGE 1: Pregnancy 5. STAGE 2: Prior irradiation of the spine site and level to be treated 6. STAGE 2: Patients with primary disease arising in the posterior elements of the VB in question 7. STAGE 2: History of Barrett's esophagus, esophageal webbing, stricture, or fistula 8. STAGE 2: Prior radiation to the esophagus
References
Publications (0)
Data not yet available
No reference posted for this study.