Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression.

NCT05109819 | Recruiting DMC

• 2 other identifiers: AA 2112 ESO-SPAREH-20069184
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Duration of gastro-oesophageal toxicity

  Assessed 9 weeks after treatment start

• Reirradiation rate - Overall survival (OS)

  Assessed 6 months after inclusion of the last patient.

• Patient reported physical function

  Assessed Weekly over a period of 9 weeks

• Health related Quality of life (QoL)

  Assessed Weekly over a period of 9 weeks

• Health related Quality of life (QoL)

  Assessed Weekly over a period of 9 weeks

Study Arms (2)

Arm A: standard radiotherapy treatment

NO INTERVENTION

Patients in arm A will receive standard radiotherapy treatment for metastatic spinal cord compression.

Arm B: esophagus sparring radiotherapy treatment

EXPERIMENTAL

Patients in arm B will receive esophagus sparring radiotherapy treatment.

Radiation: Esophagus sparring radiotherapy treatment

Interventions

Esophagus sparring radiotherapy treatment RADIATION

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

Arm B: esophagus sparring radiotherapy treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Referred for \> 10 fractions

Sponsors & Collaborators

• Herlev Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Danish Cancer Society: collaborator
• University of Copenhagen: collaborator

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Herlev Hospatal

Herlev, 2730, Denmark

RECRUITING

Related 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.

  PMID: 8433390 BACKGROUND

• 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.

  PMID: 11491192 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Compression; Radiation Injuries; Esophagitis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The outcome of randomization is not reviled to the patient.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 5, 2021
• Study Start: May 20, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)