A prospective randomised trial of adjuvant chemotherapy in node positive early stage carcinoma of the cervix
| ISRCTN | ISRCTN52711596 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52711596 |
| ClinicalTrials.gov (NCT) | NCT00003209 |
| Protocol serial number | CE3005 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 11/04/2019
- 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
Mr - -
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 | A prospective randomised trial of adjuvant chemotherapy in node positive early stage carcinoma of the 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 | Following surgery patients are randomised to either: 1. Arm A: External beam pelvic radiotherapy 2. Arm B: Adjuvant chemotherapy plus external beam radiotherapy |
| 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 | 28/02/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Key inclusion criteria | 1. Histologically proven invasive adeno or squamous cell carcinoma of the cervix 2. Histologically proven pelvic lymph node involvement 3. Stage Ib or IIa disease 4. Fit to receive either treatment arm 5. Adequate renal hepatic and haematological function 6. Adequate pulmonary function 7. Patients with a probability of <0.2 of not developing severe encephalopathy with ifosfamide/mensa treatment are excluded 8. No second primary tumour other than basal cell carcinoma of the skin 9. No other serious medical or psychological condition precluding treatment |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1990 |
| Date of final enrolment | 28/02/1996 |
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 |
Editorial Notes
11/04/2019: No publications found. All search options exhausted.
