Radiation Therapy in Treating Patients With Malignant Spinal Cord Compression Who Were Previously Treated With Radiation Therapy. ICORG 07-11
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|ClinicalTrials.gov Identifier: NCT00974168|
Recruitment Status : Active, not recruiting
First Posted : September 10, 2009
Last Update Posted : December 21, 2016
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 or disease||Intervention/treatment||Phase|
|Pain Radiation Toxicity Spinal Cord Compression Unspecified Adult Solid Tumor, Protocol Specific||Radiation: Cumulative BED ≤ 100 Radiation: Cumulative BED ≤ 130 Gy2||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||December 2016|
Active Comparator: A
Radiation Cumulative BED ≤ 100 Gy2
Radiation: Cumulative BED ≤ 100
Active Comparator: B
Cumulative BED ≤ 130 Gy2
Radiation: Cumulative BED ≤ 130 Gy2
- Response to treatment as assessed by mobility via the Tomita mobility scale [ Time Frame: 5 weeks after completion of radiation therapy ]
- Overall response rate (stabilization and response) (stage I) [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ]
- 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 ]
- 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 ]
- Pain control via the pain visual analogue score [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ]
- 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 ]
- Median survival (time from the date of recruitment/treatment to death) [ Time Frame: Until death ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974168
|Saint Luke's Radiation Oncology Network|
|Dublin, Ireland, 6|
|Galway University Hospital|
|Principal Investigator:||Pierre Thirion, MD||Saint Luke's Hospital|