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| Sponsor: | St. Luke's Hospital, Ireland |
|---|---|
| Collaborator: |
All Ireland Cooperative Oncology Research Group |
| Information provided by: | St. Luke's Hospital, Ireland |
| ClinicalTrials.gov Identifier: | NCT00624507 |
Purpose
This Phase II trial will assess and evaluate the efficacy of re-irradiation in patients presenting with malignant spinal cord compression occurring in a previously irradiation area of spinal cord.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Spinal Cord Compression |
Radiation: Radiotherapy: Radio-Biological Based Re-irradiation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Patients who received their most recent course of radiotherapy to the same area of spinal cord within the last six months
|
Radiation: Radiotherapy: Radio-Biological Based Re-irradiation
Fractionation scheme using 3 Gy per fraction resulting in a cumulative BED of 100Gy2 (less than six months since most recent RT)
|
|
2: Experimental
Patients who received their most recent course of radiotherapy to the same area of spinal cord more than six months ago
|
Radiation: Radiotherapy: Radio-Biological Based Re-irradiation
Fractionation scheme using 3 Gy per fraction resulting in a cumulative BED of 130Gy2 (more than six months since most recent RT)
|
The occurrence of Malignant Spinal Cord Compression (MSCC) in a previously irradiated area of spinal cord is a common clinical situation in oncology. Only a minority of patients are amenable to non-radiotherapy management i.e, decompression spinal surgery. Therefore, re-irradiation is often considered as the unique therapeutic option for these patients.
The re-irradiation schedule for eligible patients will be in line with in-house guidelines on cumulative Biologically Effective Dose (BED) ie., ≤100 Gy2 (<6 months since most recent RT) or ≤130 Gy2 (>6 months since most recent RT). Adherence to these guidelines ensures that the cumulative dose delivered to eligible patients carries a low or intermediate risk only, for development of radiation-induced myelopathy (RIM). The re-irradiation schedule delivered will ensure that the patient receives at least the lowest dose equivalent known to have demonstrated efficacy in MSCC, and will deliver 3Gy per fraction. The re-irradiation schedule will be determined according to two parameters : -
All patients with progressive or new neurological symptoms will have an MRI of the spine performed, which is the gold standard for imaging spinal cord. Tumour progression or recurrence is a major deferential diagnosis. All MRI's will be reviewed by a consultant radiologist. All cases with RTOG SOMA score 2+ will be handled as a serious adverse event. A review of the incidence of RTOG SOMA grade 2+ will be conducted following 14 evaluable patients: if the overall rate of RIM observed exceeds the rate reported by Nieder et al (i.e., 3% for low risk patients, 25% for intermediate risk patients) by one patient - the trial will stop.
All patients will be prescribed high-dose corticosteroids (Dexamethasone), commencing with 8mg tds and tapered according to patient response. A proton-pump inhibitor may also be prescribed, in line with current practice. All patients receiving treatment to fields below the level of T9 will receive ondansetron (Zofran) 8mg p.o. prophylactically as an anti-emetic, as per current practice.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Angela Clayton-Lea, BSc (Hons) | 00353 -1-4065000 ext 5466 | angela.claytonlea@slh.ie |
| Ireland, Rathgar, | |
| St. Luke's Hospital | Recruiting |
| Highfield Road, Rathgar,, Ireland, Dublin 6, | |
| Principal Investigator: Pierre Thirion, MD | |
| Principal Investigator: Michael Moriarty, MD | |
| Sub-Investigator: Cormac Small, MB, BCh, BAO | |
| Sub-Investigator: Orla McArdle, MB FFRRCSI | |
| Sub-Investigator: Dr Conor Collins, FRCPI FRCR | |
| Sub-Investigator: Angela Clayton-Lea, BSc (Hons) | |
| Principal Investigator: | Pierre Thirion, MD | St. Luke's Hospital, Ireland |
| Principal Investigator: | Michael Moriarty, MD | St. Luke's Hospital, Ireland |
More Information
| Responsible Party: | St. Luke's Hospital, Ireland ( Pierre Thirion ) |
| Study ID Numbers: | ICORG 07-11 |
| Study First Received: | January 29, 2008 |
| Last Updated: | May 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00624507 History of Changes |
| Health Authority: | Ireland: Medical Ethics Research Committee |
|
Malignant Spinal Cord Compression Re-irradiation of Spinal Cord Biologically Effective Dose Radiation-induced Myelopathy |
|
Spinal Cord Injuries Spinal Cord Diseases Spinal Cord Compression Nervous System Diseases |
Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases |