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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Manchester, Det Forenede Kongerige, M20 6UX
- Christie Hospital
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England
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Bristol, England, Det Forenede Kongerige, BS2 8ED
- Bristol Haematology and Oncology Centre
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Northwood, England, Det Forenede Kongerige, HA6 2RN
- Cancer Research UK and University College London Cancer Trials Centre
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Wales
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Rhyl, Denbighshire, Wales, Det Forenede Kongerige, LL 18 5UJ
- Glan Clwyd Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Arm I (multi-fraction radiotherapy)
Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
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Patients undergo external beam radiotherapy
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Eksperimentel: Arm II (single-fraction radiotherapy)
Patients undergo 1 fraction of 8 Gy external beam radiotherapy.
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Patients undergo external beam radiotherapy
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Patient accrual per center over a 12-month period
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Sekundære resultatmål
Resultatmål |
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Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
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Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
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Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment
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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
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Further treatment
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Overall survival at 3, 6, and 12 months
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Total number of days spent in hospital
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Preferred place of care
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Number of patients eligible but not randomized and reasons for non-randomization
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000599886
- CRUK-UCL-BRD-07-010
- CRUK-SCORAD
- ISRCTN97555949
- EU-20863
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