An interventional study of Esophagus sparring radiotherapy treatment in Metastatic Spinal Cord Compression, Radiation Toxicity and Esophagitis, sponsored by Herlev Hospital. Recruiting at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Herlev Hospital · Not applicable, Interventional, and Prevention
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.
52 studies on the registry are indexed under Spinal Cord Compression; 19 are open to participants now.
This study's planned enrollment of 200 is above the median of 43 across 35 interventional studies indexed under Spinal Cord Compression.
Browse Spinal Cord Compression studies →Herlev Hospital is the lead sponsor of 201 studies on the registry; 24 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Referred for palliative radiotherapy of the cervical or thoracic vertebra for
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in arm A will receive standard radiotherapy treatment for metastatic spinal cord compression.
Patients in arm B will receive esophagus sparring radiotherapy treatment.
Radiation: Esophagus sparring radiotherapy treatment
A radiotherapy plan for metastatic spinal cord compression is conducted with specific constrains sparring the esophagus.
Early patient reported gastro-oesophageal toxicity
Measured as a peak score using CTCAE Patient Reported Outcome Measures
Time frame: Measured within the first 5 weeks after treatment start
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).
Time frame: Measured 9 weeks after treatment start
Duration of gastro-oesophageal toxicity
Measured as the time from an increase in gastro-oesophageal symptom score to a return to baseline
Time frame: Assessed 9 weeks after treatment start
Reirradiation rate - Overall survival (OS)
Defined as fraction of patients getting reirradiation, where the same spine levels are included in the irradiated volume
Time frame: Assessed 6 months after inclusion of the last patient.
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.
Time frame: Assessed Weekly over a period of 9 weeks
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).
Time frame: Assessed Weekly over a period of 9 weeks
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.
Time frame: Assessed Weekly over a period of 9 weeks
Weight
Assessed Weekly over a period of 9 weeks
Time frame: Assessed Weekly over a period of 9 weeks
Analgesic consumption
Assessed Weekly over a period of 9 weeks
Time frame: Assessed Weekly over a period of 9 weeks
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).
Time frame: Assessed daily for 5 weeks and subsequently weekly for 4 weeks.
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.
Time frame: Best response during 9 weeks of follow-up
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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