- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00727584
Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression
SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating metastatic spinal cord compression.
PURPOSE: This randomized clinical trial is comparing two radiation therapy regimens to see how well they work in treating patients with metastatic spinal cord compression.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
- To examine whether a phase III randomized study comparing a single-fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and to patients with metastatic spinal cord compression.
- To determine the feasibility of conducting this study in the United Kingdom.
OUTLINE: This is a multicenter study. Patients are stratified by treatment center and known prognostic factors (ambulatory status at diagnosis, primary tumor type, and extent of disease [spinal metastases only vs spinal and non-bony metastases]). Patients are randomized to 1 of 2 treatment arms.
- Arm I (multi-fraction radiotherapy): Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
- Arm II (single-fraction radiotherapy): Patients undergo 1 fraction of 8 Gy external beam radiotherapy.
Patients undergo assessment of ambulatory status, quality of life, bladder and bowel function, and acute toxicity via self-reported questionnaires and telephone follow-ups at baseline and weeks 1, 4, 8, and 12.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Manchester, Storbritannien, M20 6UX
- Christie Hospital
-
-
England
-
Bristol, England, Storbritannien, BS2 8ED
- Bristol Haematology and Oncology centre
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Northwood, England, Storbritannien, HA6 2RN
- Cancer Research UK and University College London Cancer Trials Centre
-
-
Wales
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Rhyl, Denbighshire, Wales, Storbritannien, LL 18 5UJ
- Glan Clwyd Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignant disease
Proven diagnosis of metastatic spinal cord compression on MRI or CT scan
- Single site of compression OR multiple sites that can be treated within a single radiation treatment field
- No patient for whom surgery or chemotherapy treatment is more appropriate
- No multiple myeloma as primary cancer
PATIENT CHARACTERISTICS:
- Life expectancy > 1 month
- Not pregnant
- Willing and able to complete assessment forms
- Able to give informed consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Arm I (multi-fraction radiotherapy)
Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
|
Patients undergo external beam radiotherapy
|
Experimentell: Arm II (single-fraction radiotherapy)
Patients undergo 1 fraction of 8 Gy external beam radiotherapy.
|
Patients undergo external beam radiotherapy
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
---|
Patient accrual per center over a 12-month period
|
Sekundära resultatmått
Resultatmått |
---|
Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
|
Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
|
Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment
|
Quality of life as measured by the EORTC QLQ-C30 questionnaire at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
|
Further treatment
|
Overall survival at 3, 6, and 12 months
|
Total number of days spent in hospital
|
Preferred place of care
|
Number of patients eligible but not randomized and reasons for non-randomization
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CDR0000599886
- CRUK-UCL-BRD-07-010
- CRUK-SCORAD
- ISRCTN97555949
- EU-20863
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