Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression. (ESO-SPARE)

Herlev Hospital

Status: Enrolling

Conditions: Esophagitis; Metastatic Spinal Cord Compression; Radiation Toxicity; Patient Reported Outcome Measures

Treatments: Radiation: Esophagus sparring radiotherapy treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05109819

H-20069184 (Registry Identifier)

AA 2112 ESO-SPARE

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Arm A: standard radiotherapy treatment

No Intervention group

Description:

Patients in arm A will receive standard radiotherapy treatment for metastatic spinal cord compression.

Arm B: esophagus sparring radiotherapy treatment

Experimental group

Description:

Patients in arm B will receive esophagus sparring radiotherapy treatment.

Treatment:

Radiation: Esophagus sparring radiotherapy treatment