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ISRCTN
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ISRCTN38929731
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ClinicalTrials.gov identifier
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Public title
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Comparison of radical radiotherapy with or without chemotherapy for poor prognosis carcinoma of 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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G34
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Study hypothesis
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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 diagnosed squamous cell carcinoma of the cervix uteri
2. International Federation of Gynecology and Obstetrics (FIGO) stage III, IVa or bulky stage II
3. No evidence of extra pelvic spread
4. Aged <70 years
5. World Health Organisation (WHO) performance 0-2
6. Suitable for radical radiotherapy
7. Suitable for chemotherapy
8. Adequate haematological and renal function
9. No history of previous malignancy, excluding successfully treated squamous and basal cell carcinoma of skin or carcinoma in situ of the cervix
10. No previous chemotherapy or radiotherapy
11. No contraindications to treatment
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1992
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Anticipated end date
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24/08/1997
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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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Not provided at time of registration
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Interventions
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1. Arm A: Chemotherapy with methotrexate and cisplatinum repeated every 14 days for three cycles. Radiotherapy consisting of a course of external beam therapy followed by intracavity brachytherapy to start 14 days after the third course of chemotherapy. External beam therapy, a central tumour dose of 40 Gy in twenty fractions over 4 weeks. Intracavity brachytherapy, a dose of 32.5 Gy to point A in a single insertion.
2. Arm B: Radiotherapy consisting of a course of external beam therapy followed by intracavity brachytherapy to start as soon as possible following randomisation. External beam therapy, a central tumour dose of 40 Gy in twenty fractions over 4 weeks. Intracavity brachytherapy, a dose of 32.5 Gy to point A in a single insertion.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
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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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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21/05/2008
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Date ISRCTN assigned
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01/07/2001
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