Trials / Recruiting
RecruitingNCT05109819
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.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Herlev Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Metastatic spinal cord compression (MSCC) is a serious complication to metastatic cancer and when diagnosed life expectancy is short. Treatment is palliative radiotherapy (RT). Early esophageal toxicity is underreported but can seriously impact quality of life (QoL). The aim of the ESO-SPARE trial is to investigate if esophagus sparing RT can decrease patient reported esophageal toxicity without compromising ambulatory function or increase other toxicities. 200 patients with MSCC in the thoracic or cervical spine referred for RT will be randomized to either standard or esophagus/pharynx sparing RT. Subsequently participants will be followed with PROM (Patient Reported Outcome Measures) for 9 weeks. PROM-CTCAE questionnaires on upper GI toxicity and pain will be collected daily for 5 weeks and weekly for 4 weeks. Questionnaires evaluating QoL and physical function will be collected weekly for 9 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Esophagus sparring radiotherapy treatment | A radiotherapy plan for metastatic spinal cord compression is conducted with specific constrains sparring the esophagus. |
Timeline
- Start date
- 2021-05-20
- Primary completion
- 2024-05-01
- Completion
- 2024-05-01
- First posted
- 2021-11-05
- Last updated
- 2024-05-01
Locations
2 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT05109819. Inclusion in this directory is not an endorsement.