| Source of record | UK Trials |
| ISRCTN | ISRCTN38929731 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | G34 |
| Public title | Comparison of radical radiotherapy with or without chemotherapy for poor prognosis carcinoma of cervix |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cervix |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 24/08/1997 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients are randomised to one of two treatment arms:
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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN38929731 |
| Date last extracted from ISRCTN register | 17/04/2008 |
