Randomised controlled clinical trial of oral etoposide versus intravenous multi-drug chemotherapy in the palliative treatment of patients with Small-Cell Lung Cancer (SCLC) and a poor prognosis
ISRCTN | ISRCTN71172156 |
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DOI | https://doi.org/10.1186/ISRCTN71172156 |
Secondary identifying numbers | LU16 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 15/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Randomised controlled clinical trial of oral etoposide versus intravenous multi-drug chemotherapy in the palliative treatment of patients with Small-Cell Lung Cancer (SCLC) and a poor prognosis |
Study objectives | Not provided at time of registration. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Small-Cell Lung Cancer (SCLC) |
Intervention | 1. Oral Etoposide Regimen (E): Four courses of oral etopsimide twice daily for ten days at three week intervals (i.e. ten days of chemotherapy in each three week period). 2. Intravenous Multi-Drug Chemotherapy Regimen (EV or CAV): Clinicians chose to use one of two multi-drug chemotherapy regimens: EV: Intravenous etoposide and vincristine four courses given at three week intervals, each course given over three days according to the protocol. CAV: Intravenous cyclophosphamide, doxorubicin and vincristine four courses given at three week intervals, each course given on one day. All treatments should start as soon as possible after randomisation. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Etopsimide, cyclophosphamide, doxorubicin and vincristine |
Primary outcome measure | Not provided at time of registration. |
Secondary outcome measures | Not provided at time of registration. |
Overall study start date | 01/08/2002 |
Completion date | 01/08/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | Not provided at time of registration. |
Total final enrolment | 339 |
Key inclusion criteria | 1. Microscopically proven SCLC 2. Limited or extensive disease 3. World Health Organisation (WHO) performance status grade two, three or four 4. No previous chemotherapy, radiotherapy, or surgery for small-cell lung cancer 5. No other previous or concomitant malignant disease, except basal cell carcinoma or in situ carcinoma of the cervix 6. No other serious condition contraindicating treatment with cytotoxic chemotherapy. Patients with evidence of liver cell damage are eligible 7. Renal function normal: plasma creatinine or urea concentration within normal limits 8. Plasma Billirubin less than 35 µmol/l 9. Any age, either sex |
Key exclusion criteria | Not provided at time of registration. |
Date of first enrolment | 01/08/2002 |
Date of final enrolment | 01/08/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
Phone | +44 (0)20 7636 5422 |
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clinical.trial@headoffice.mrc.ac.uk | |
Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 31/08/1996 | 15/11/2019 | Yes | No |
Editorial Notes
15/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.