Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression.
NCT ID: NCT05109819
Last Updated: 2024-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2021-05-20
2024-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Arm A: standard radiotherapy treatment
Patients in arm A will receive standard radiotherapy treatment for metastatic spinal cord compression.
No interventions assigned to this group
Arm B: esophagus sparring radiotherapy treatment
Patients in arm B will receive esophagus sparring radiotherapy treatment.
Esophagus sparring radiotherapy treatment
A radiotherapy plan for metastatic spinal cord compression is conducted with specific constrains sparring the esophagus.
Interventions
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Esophagus sparring radiotherapy treatment
A radiotherapy plan for metastatic spinal cord compression is conducted with specific constrains sparring the esophagus.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Danish Cancer Society
OTHER
University of Copenhagen
OTHER
Herlev Hospital
OTHER
Responsible Party
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Anna Mann Nielsen
Principal Investigator, MD
Locations
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Rigshospitalet
Copenhagen, , Denmark
Herlev Hospatal
Herlev, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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H-20069184
Identifier Type: REGISTRY
Identifier Source: secondary_id
AA 2112 ESO-SPARE
Identifier Type: -
Identifier Source: org_study_id
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