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RECRUITING
NCT05109819
NA

Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression.

Sponsor: Herlev Hospital

View on ClinicalTrials.gov

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.

Official title: ESO-SPARE: Esophagus Sparring Radiotherapy for Thoracic and Cervical Metastatic Spinal Cord Compression. A Randomized Phase III Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2021-05-20

Completion Date

2024-05

Last Updated

2024-05-01

Healthy Volunteers

No

Interventions

RADIATION

Esophagus sparring radiotherapy treatment

A radiotherapy plan for metastatic spinal cord compression is conducted with specific constrains sparring the esophagus.

Locations (2)

Rigshospitalet

Copenhagen, Denmark

Herlev Hospatal

Herlev, Denmark