Clinical trial NCT05109819: Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression.
Official title: ESO-SPARE: Esophagus Sparring Radiotherapy for Thoracic and Cervical Metastatic Spinal Cord Compression. A Randomized Phase III Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Spinal Cord Compression
Radiation Toxicity
Esophagitis
Patient Reported Outcome Measures
Keywords: Metastatic Spinal Cord Compression
Radiation Toxicity
Esophagitis
Patient reported outcome measures
Palliative radiotherapy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Danish Cancer Society
name: University of Copenhagen
First posted: 2021-11-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with metastatic spinal cord compression in the cervical and/or thoracic spine are randomized into two groups. Group A receives standard radiotherapy, group B receives esophagus sparing therapy.
Primary purpose: PREVENTION

Brief 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 criteria: 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

Primary outcomes:
measure: Early patient reported gastro-oesophageal toxicity
timeFrame: Measured within the first 5 weeks after treatment start
measure: Ambulatory function
timeFrame: Measured 9 weeks after treatment start
Secondary outcomes:
measure: Duration of gastro-oesophageal toxicity
timeFrame: Assessed 9 weeks after treatment start
measure: Reirradiation rate - Overall survival (OS)
timeFrame: Assessed 6 months after inclusion of the last patient.
measure: Patient reported physical function
timeFrame: Assessed Weekly over a period of 9 weeks
measure: Health related Quality of life (QoL)
timeFrame: Assessed Weekly over a period of 9 weeks
measure: Health related Quality of life (QoL)
timeFrame: Assessed Weekly over a period of 9 weeks
measure: Weight
timeFrame: Assessed Weekly over a period of 9 weeks
measure: Analgesic consumption
timeFrame: Assessed Weekly over a period of 9 weeks
measure: Pain (MSCC site)
timeFrame: Assessed daily for 5 weeks and subsequently weekly for 4 weeks.
measure: Pain assessment (MTS site)
timeFrame: Best response during 9 weeks of follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev Hospatal
Study officials:
References:
citation: Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
citation: Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.