RecruitingNot ApplicableNCT05109819

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.

Sponsor

Herlev Hospital

Enrollment

200 participants

Start Date

May 20, 2021

Study Type

INTERVENTIONAL

Conditions

Patient Reported Outcome Measures Radiation Toxicity Esophagitis Metastatic Spinal Cord Compression

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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.