Esophagus-sparing radiotherapy for metastatic spinal cord compression
ESO-SPARE: Esophagus Sparring Radiotherapy for Thoracic and Cervical Metastatic Spinal Cord Compression. A Randomized Phase III Study.
NA · Herlev Hospital · NCT05109819
This study is testing a new type of radiation therapy that protects the esophagus to see if it helps people with metastatic spinal cord compression feel better and have fewer side effects compared to standard treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev Hospital (other) |
| Locations | 2 sites (Copenhagen and 1 other locations) |
| Trial ID | NCT05109819 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of esophagus-sparing radiotherapy in reducing esophageal toxicity in patients with metastatic spinal cord compression (MSCC). It aims to determine if this approach can maintain ambulatory function and minimize other toxicities compared to standard radiotherapy. A total of 200 patients will be randomized to receive either standard or esophagus/pharynx sparing radiotherapy, with their outcomes monitored through patient-reported outcome measures over a period of 9 weeks. Daily and weekly questionnaires will assess upper gastrointestinal toxicity, pain, quality of life, and physical function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically or cytologically proven cancer referred for palliative radiotherapy for cervical or thoracic spinal issues related to metastatic disease.
Not a fit: Patients who are referred for more than 10 fractions of radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients undergoing treatment for metastatic spinal cord compression by reducing esophageal toxicity.
How similar studies have performed: While the specific approach of esophagus-sparing radiotherapy is novel, similar studies have shown promise in reducing treatment-related toxicities in cancer care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histology or cytology proven cancer * Referred for palliative radiotherapy of the cervical or thoracic vertebra for * epidural ingrowth * metastatic spinal cord compression * metastatic spinal nerve root compression * post-operative radiotherapy after decompressive surgery for spinal cord or nerve root compression * Ability to understand and the willingness to sign a written informed consent document * Referred for the following dose prescriptions 5 Gy x 5, 5 Gy x 4, 3 Gy x 10, 10 Gy x 1, 8 Gy x 1. * ≥ 18 years old. Exclusion Criteria: - Referred for \> 10 fractions
Where this trial is running
Copenhagen and 1 other locations
- Rigshospitalet — Copenhagen, Denmark (RECRUITING)
- Herlev Hospatal — Herlev, Denmark (RECRUITING)
Study contacts
- Study coordinator: Anna M Nielsen, MD
- Email: anna.mann.nielsen@regionh.dk
- Phone: 00 45 26718136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Spinal Cord Compression, Radiation Toxicity, Esophagitis, Patient Reported Outcome Measures, Patient reported outcome measures, Palliative radiotherapy