Clinical trial · Interventional
Spinal Cord Compression. ICORG 05-03, V6
A Randomised Phase III Trial of Two Fractionation Schemes in the Treatment of Malignant Spinal Cord Compression
NCT00968643CI-TRIAL-00016484completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy schedule is more effective in treating patients with malignant spinal cord compression. PURPOSE: This randomized phase III trial is studying two different radiation therapy schedules to compare their side effects and how well they work in treating patients with malignant spinal cord compression.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Spinal Cord Compression | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (control)
- description
- Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).
- interventionNames
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).
- interventionNames
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignancy, excluding the following: * Leukemia * Myeloma * Germ cell tumor * Primary tumor of the spine or vertebral column * Diagnosis of malignant spinal cord compression confirmed by MRI of the entire spine * Deemed inoperable or unsuitable for neurosurgical intervention at the time of initial assessment * No single bone metastasis with controlled primary site PATIENT CHARACTERISTICS: * Karnofsky performance status 30-100% * No medical or psychiatric condition that, in the opinion of the investigator or research team, would contraindicate study participation PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the involved area of the spinal cord such that further treatment exceeds spinal cord tolerance
References
Publications (1)
- DERIVEDThirion PG, Dunne MT, Kelly PJ, Flavin A, O'Sullivan JM, Hacking D, Sasiadek W, Small C, Pomeroy MM, Martin J, McArdle O, Parker I, O'Sullivan LS, Shannon AM, Clayton-Lea A, Collins CD, Stevenson MR, Alvarez-Iglesias A, Armstrong JG, Moriarty M. Non-inferiority randomised phase 3 trial comparing two radiation schedules (single vs. five fractions) in malignant spinal cord compression. Br J Cancer. 2020 Apr;122(9):1315-1323. doi: 10.1038/s41416-020-0768-z. Epub 2020 Mar 11. PMID 32157242