Comparison of radical radiotherapy with or without chemotherapy for poor prognosis carcinoma of cervix
| ISRCTN | ISRCTN38929731 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38929731 |
| Protocol serial number | G34 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 10/03/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
- -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Comparison of radical radiotherapy with or without chemotherapy for poor prognosis carcinoma of cervix |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cervix cancer |
| Intervention | 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. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 24/08/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1992 |
| Date of final enrolment | 24/08/1997 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
