Oral chemotherapy versus intravenous chemotherapy in limited or extensive small cell lung cancer
| ISRCTN | ISRCTN81334858 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81334858 |
| Protocol serial number | LU309 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 18/09/2017
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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
Dr - -
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 |
| Study type | Participant information sheet |
| Scientific title | Oral chemotherapy versus intravenous chemotherapy in limited or extensive small cell lung cancer: a randomised controlled trial |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lung (small cell) |
| Intervention | 1. Oral Regimen: Oral etoposide and cyclophosphamide given over 5 days every 3 weeks. 2. Intravenous Regimen: Intravenous combination of three or more drugs routinely used in the centre with the usual dose reduction. A standard alternative is adriamycin, cyclophosphamide and vincristine (VAC) repeated every 3 weeks. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2000 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Key inclusion criteria | 1. Histologically or cytologically proven small cell lung cancer 2. No previous or concurrent malignancy 3. Fit to receive chemotherapy 4. No prior chemotherapy or radiotherapy 5. No biochemical or haematological abnormalities which would preclude chemotherapy |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1995 |
| Date of final enrolment | 31/12/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | interim results | 31/08/1996 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/09/2017: internal review.