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ISRCTN
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ISRCTN54178182
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DOI
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10.1186/ISRCTN54178182
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ClinicalTrials.gov identifier
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NCT00003209
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EudraCT number
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Public title
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A randomised trial of chemotherapy and radiotherapy versus radiotherapy alone as adjuvant treatment in women with node positive operable cancer of the cervix
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Scientific title
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Acronym
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N/A
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Serial number at source
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CE04
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Study hypothesis
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To compare post-operative cisplatin-based chemotherapy and radiotherapy with radiotherapy alone in patients with node positive stage IB or IIA cancer of the cervix.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cervix cancer
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Participants - inclusion criteria
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1. Histologically confirmed cancer of the cervix with: Squamous, adenosquamous or adencarcinoma cell type/International Federation of Gynecology and Obstetrics (FIGO) stage IB or IIA/Nodal involvement (of any extent)
2. Patient fit to receive, and with no contraindication to, cisplatin-based chemotherapy
3. Patient should have undergone a radical hysterectomy, a pelvic lymphadenectomy and resection of any suspicious (enlarged) common iliac or para-aortic lymph nodes where appropriate
4. No concomitant or previous malignancy likely to interfere with protocol treatments or comparisons
5. Written informed consent
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Participants - exclusion criteria
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1. WBC less than 3.5 x 10 to the power of 9 per litre
2. Platelets less than 100 x 10 to the power of 9 per litre
3. Bilirubin more than 1.25 times the upper limit of normal
4. Glomerular filtration rate less than 50 millilitres per minute
5. Uncontrolled or potentially active site of infection (eg fistula or abscesses)
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Anticipated start date
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01/04/1998
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Anticipated end date
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25/04/2000
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1000
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Interventions
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1. Post-operative cisplatin-based chemotherapy and radiotherapy
2. Radiotherapy alone
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Primary outcome measure(s)
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Primary endpoint is survival, defined as time from randomisation to death (from any cause).
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Secondary outcome measure(s)
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Secondary endpoints are progression-free survival, site of relapse, toxicity-free survival and quality of life.
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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Contact name
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Ms
Claire
Amos
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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06/04/2000
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Last edited
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01/02/2013
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Date ISRCTN assigned
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06/04/2000
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