Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression.

Radiation Toxicity Clinical Trial

— ESO-SPARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05109819
• Other study ID #: AA 2112 ESO-SPARE
• Secondary ID: H-20069184
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Herlev Hospital
• Contact: Anna M Nielsen, MD
• Phone: 00 45 26718136
• Email: anna.mann.nielsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis
• Patient Reported Outcome Measures
• Radiation Toxicity
• Spinal Cord Compression

Intervention

Radiation:
• Esophagus sparring radiotherapy treatment
A radiotherapy plan for metastatic spinal cord compression is conducted with specific constrains sparring the esophagus.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev Hospatal	Herlev

Sponsors (4)

Lead Sponsor	Collaborator
Herlev Hospital	Danish Cancer Society, Rigshospitalet, Denmark, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early patient reported gastro-oesophageal toxicity	Measured as a peak score using CTCAE Patient Reported Outcome Measures	Measured within the first 5 weeks after treatment start
Primary	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 9 weeks after treatment start
Secondary	Duration of gastro-oesophageal toxicity	Measured as the time from an increase in gastro-oesophageal symptom score to a return to baseline	Assessed 9 weeks after treatment start
Secondary	Reirradiation rate - Overall survival (OS)	Defined as fraction of patients getting reirradiation, where the same spine levels are included in the irradiated volume	Assessed 6 months after inclusion of the last patient.
Secondary	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.	Assessed Weekly over a period of 9 weeks
Secondary	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).	Assessed Weekly over a period of 9 weeks
Secondary	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.	Assessed Weekly over a period of 9 weeks
Secondary	Weight	Assessed Weekly over a period of 9 weeks	Assessed Weekly over a period of 9 weeks
Secondary	Analgesic consumption	Assessed Weekly over a period of 9 weeks	Assessed Weekly over a period of 9 weeks
Secondary	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).	Assessed daily for 5 weeks and subsequently weekly for 4 weeks.
Secondary	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.	Best response during 9 weeks of follow-up