Radiation Therapy in Treating Patients With Malignant Spinal Cord Compression Who Were Previously Treated With Radiation Therapy
This study is currently recruiting participants.
Verified October 2012 by ICORG- All Ireland Cooperative Oncology Research Group
Sponsor:
ICORG- All Ireland Cooperative Oncology Research Group
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00974168
First received: September 9, 2009
Last updated: October 15, 2012
Last verified: October 2012
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may be effective in treating malignant spinal cord compression in patients who have received previous radiation therapy to the spine.
PURPOSE: This phase II trial is studying radiation therapy in treating patients with malignant spinal cord compression.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Radiation Toxicity Spinal Cord Compression Unspecified Adult Solid Tumor, Protocol Specific |
Radiation: Cumulative BED ≤ 100 Radiation: Cumulative BED ≤ 130 Gy2 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression |
Resource links provided by NLM:
Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:
Primary Outcome Measures:
- Response to treatment as assessed by mobility via the Tomita mobility scale [ Time Frame: 5 weeks after completion of radiation therapy ] [ Designated as safety issue: No ]
- Overall response rate (stabilization and response) (stage I) [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ] [ Designated as safety issue: Yes ]
- Toxicity other than spine (acute toxicity assessed at weeks 1 and 5 and late toxicity assessed at 3 months and at subsequent follow-ups) evaluated according to RTOG criteria [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ] [ Designated as safety issue: Yes ]
- Pain control via the pain visual analogue score [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ] [ Designated as safety issue: No ]
- Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ] [ Designated as safety issue: No ]
- Median survival (time from the date of recruitment/treatment to death) [ Time Frame: Until death ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | October 2007 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Radiation Cumulative BED ≤ 100 Gy2
|
Radiation: Cumulative BED ≤ 100
Radiation
|
|
Active Comparator: B
Cumulative BED ≤ 130 Gy2
|
Radiation: Cumulative BED ≤ 130 Gy2
Radiation
|
Detailed Description:
OBJECTIVES:
Primary
- To determine the efficacy of a biologically effective dose-based re-irradiation strategy, in terms of the response rate (based on the mobility score using the Tomita scale where improvement in mobility or stable mobility score will be regarded as a response) in patients with malignant spinal cord compression.
Secondary
- To determine quality of life as assessed by the EORTC QLQ-C15 PAL version 1.0 questionnaire.
- To determine the non-spinal radiation-induced toxicity using standard RTOG criteria.
- To determine the rate of long-term spinal toxicity and radiation-induced myelopathy using the RTOG SOMA morbidity grading system.
OUTLINE: Patients are divided into 2 groups according to the interval since their most recent radiotherapy to the involved area of the spinal cord.
- Group 1 (< 6 months since prior radiotherapy): Patients undergo radiotherapy for a cumulative biologically effective dose (BED) ≤ 100 Gy_2 in addition to receiving other current treatment.
- Group 2 (≥ 6 months since prior radiotherapy): Patients undergo radiotherapy for a cumulative BED ≤ 130 Gy_2 in addition to receiving other current treatment.
Mobility score is assessed and patients complete a quality-of-life assessment at baseline and at each follow-up visit starting at week 5.
After completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months, and then every 3 months thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
MRI-confirmed diagnosis of malignant spinal cord compression
- MRI of the entire spine performed
Histologically proven malignancy
- No primary tumors of the spine or vertebral column
Undergone previous radiotherapy to the involved area of the spinal cord (e.g., full segment and/or ≥ 2 cm in cranio-caudal of overlap between the 2 areas treated)
- Maximum biologically effective dose received from previous irradiation ≤ 90 Gy_2
Deemed not suitable for neurosurgical intervention at the time of initial assessment
- Patients deemed inoperable are eligible
PATIENT CHARACTERISTICS:
- Karnofsky performance status 40-100%
- Short life expectancy
- No medical or psychiatric condition that, in the opinion of the investigator or research team, contraindicates participation in this study
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974168
Locations
| Ireland | |
| Saint Luke's Radiation Oncology Network | Recruiting |
| Dublin, Ireland, 6 | |
| Contact: Pierre Thirion, MD 353-1-406-5000 | |
| Galway University Hospital | Recruiting |
| Galway, Ireland | |
| Contact: Cormac Small 353-91-893-487 | |
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
Investigators
| Principal Investigator: | Pierre Thirion, MD | Saint Luke's Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICORG- All Ireland Cooperative Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT00974168 History of Changes |
| Obsolete Identifiers: | NCT00624507 |
| Other Study ID Numbers: | CDR0000644385, ICORG-07-11, EU-20953 |
| Study First Received: | September 9, 2009 |
| Last Updated: | October 15, 2012 |
| Health Authority: | Ireland: Irish Medicines Board |
Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
|
pain radiation toxicity spinal cord compression unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Spinal Cord Compression Radiation Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Spinal Cord Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013