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Metastatic Spinal Cord CompressionESO-SPARENCT05109819

Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression.

A study testing Esophagus sparring radiotherapy treatment in people with Metastatic Spinal Cord Compression and Radiation Toxicity, run by Herlev Hospital at 2 sites in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Esophagus sparring radiotherapy treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesDenmark
Study dates
20 May 2021to May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • Referred for > 10 fractions

Trial locations and contacts

2 sites in 1 country.

Anna M Nielsen, MD contact

00 45 26718136

anna.mann.nielsen@regionh.dk

Gitte Persson, MD, Ph.d. contact

00 45 38689299

Gitte.Persson@regionh.dk

Denmark2 sites, 2 recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Morten H Suppli, MD, PhD., 00 45 35459698, morten.hiul.suppli@regionh.dk

    Ivan R Vogelius, Dr. med, clinical proffesor, 00 45 35459885, ivan.richter.vogelius@regionh.dk

    Recruiting

  • Herlev Hospatal

    Herlev, 2730

    Anna M Nielsen, +4526718136, anna.mann.nielsen@regionh.dk

    Gitte Persson, +4538689299, Gitte.Persson@regionh.dk

    Recruiting

Other trials in Denmark

About this study

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

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.

Being tested
Esophagus sparring radiotherapy treatment
Keywords
Metastatic Spinal Cord Compression, Radiation Toxicity, Esophagitis, Patient reported outcome measures, Palliative radiotherapy
Medical subject headings
Spinal Cord Compression, Radiation Injuries, Esophagitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Esophagus sparring radiotherapy treatmentRadiation

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

Study groups in NCT05109819
Study groupRoleWhat they receive
Arm A: standard radiotherapy treatmentNo interventionPatients in arm A will receive standard radiotherapy treatment for metastatic spinal cord compression.
Arm B: esophagus sparring radiotherapy treatmentExperimentalPatients in arm B will receive esophagus sparring radiotherapy treatment.
Receives: Radiation: Esophagus sparring radiotherapy treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early patient reported gastro-oesophageal toxicity

    Measured as a peak score using CTCAE Patient Reported Outcome Measures

    Measured: Measured within the first 5 weeks after treatment start

  2. Ambulatory function

    Preserved ability to walk will be evaluated using the European Quality of Life - 5 Dimensions questionnaire (EQ-5D-5L) mobility dimension. The EQ-5D includes one question for each of the five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5).

    Measured: Measured 9 weeks after treatment start

Secondary outcomes (9)

  1. Duration of gastro-oesophageal toxicity

    Measured as the time from an increase in gastro-oesophageal symptom score to a return to baseline

    Measured: Assessed 9 weeks after treatment start

  2. Reirradiation rate - Overall survival (OS)

    Defined as fraction of patients getting reirradiation, where the same spine levels are included in the irradiated volume

    Measured: Assessed 6 months after inclusion of the last patient.

  3. Patient reported physical function

    Patient reported physical function will be assessed using answers from the EORTC QLQ-C30 questionnaire. Questions regarding physical function are measured on a four-point scale (1= not at all, 2 = a little, 3 = quite a bit, 4 = very much). All EORTC QLQ-C30 answers will be scored according to the EORTC QLQ-C30 Scoring Manual.

    Measured: Assessed Weekly over a period of 9 weeks

  4. Health related Quality of life (QoL)

    Health related quality of life measured with EQ-5D-5L European Quality of Life - 5 Dimensions questionnaire (EQ-5D-5L).

    The EQ-5D includes one question for each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). Health state scores are defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).

    A visual analogue scale indicating the respondent's own assessment of their health status from 0-100 is also included (100 = the best health you can imagine and 0 = the worst health you can imagine).

    Measured: Assessed Weekly over a period of 9 weeks

  5. Health related Quality of life (QoL)

    Health related quality of life assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire - Cancer (QLQ-C30). The EORTC QLQ-C30 consists of 30 questions assessing quality of life issues using a four-point scale (1= not at all, 2 = a little, 3 = quite a bit, 4 = very much) except from the last two questions which are measured between 1 (Very Poor) to 7 (Excellent). The EORTC QLQ-C30 will be scored according to the EORTC QLQ-C30 Scoring Manual.

    Measured: Assessed Weekly over a period of 9 weeks

  6. Weight

    Assessed Weekly over a period of 9 weeks

    Measured: Assessed Weekly over a period of 9 weeks

  7. Analgesic consumption

    Assessed Weekly over a period of 9 weeks

    Measured: Assessed Weekly over a period of 9 weeks

  8. Pain (MSCC site)

    Evaluated by "Numeric Pain Rating Scale (NPRS)"

    The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

    Measured: Assessed daily for 5 weeks and subsequently weekly for 4 weeks.

  9. Pain assessment (MTS site)

    Assessment will be performed using International Consensus Pain Response Endpoints (ICPRE).

    • A complete pain response is defined as a pain score of 0 out of 10 at the treated site with no concomitant increase in analgesic intake
    • A partial pain response is defined as a pain reduction of 2 or more at the treated site without analgesic increase, or an analgesic reduction of 25% with no increase in pain score or 1 point above baseline.
    • Pain progression is defined as an increase in pain score of 2 or more above baseline with stable analgesic intake or an analgesic increase of 25% with stable pain score.
    • An indeterminate response is any response not captured in the above definitions.

    Analysis of pain reduction will only include patients with NPRS ≥ 1 registered at baseline. We intend to report the best response during follow-up.

    Measured: Best response during 9 weeks of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2021
  2. Study start20 May 2021
  3. Primary completionMay 2024 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05109819
Sponsor's protocol ID
AA 2112 ESO-SPARE
Other IDs
H-20069184
Acronym
ESO-SPARE
Status last verified
Apr 2024
First submitted
7 Oct 2021
Last updated
1 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 8433390

  • 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.

    PubMed 11491192

  • Nielsen AM, Laursen MRT, Rechner LA, Krog SM, Storm KS, Ottosson W, Gram VR, Suppli MH, Sibolt P, Vogelius IR, Behrens CP, Persson G. Esophagus-sparing radiotherapy for complicated spinal metastases (ESO-SPARE). A randomized phase III clinical trial. Radiother Oncol. 2025 Jun;207:110906. doi: 10.1016/j.radonc.2025.110906. Epub 2025 May 4.

    PubMed 40324910

Questions about this trial

What is this clinical trial studying?

A study testing Esophagus sparring radiotherapy treatment in people with Metastatic Spinal Cord Compression and Radiation Toxicity, run by Herlev Hospital at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anna M Nielsen, MD (00 45 26718136, anna.mann.nielsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early patient reported gastro-oesophageal toxicity (time frame: Measured within the first 5 weeks after treatment start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05109819, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.

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