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Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression.

NCT05109819 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-05-01

No results posted yet for this study

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

  • Metastatic Spinal Cord Compression
  • Radiation Toxicity
  • Esophagitis
  • Patient Reported Outcome Measures

Interventions

RADIATION

Esophagus sparring radiotherapy treatment

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

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Danish Cancer Society

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Herlev Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05109819 on ClinicalTrials.gov