CarVin versus CarEto - A randomised phase II study of carboplatin and vinorelbine versus carboplatin and etoposide in good performance status small cell lung cancer patients presenting with adverse prognostic factors
| ISRCTN | ISRCTN44486227 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44486227 |
| Protocol serial number | N0067120650 |
| Sponsor | Department of Health (UK) |
| Funder | Clatterbridge Centre for Oncology NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 04/07/2011
- 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 Ernie Marshall
Scientific
Scientific
Clatterbridge Centre for Oncology
Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom
| Phone | +44 0151 334 1155 |
|---|---|
| ernie.marshall@ccotrust.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | A randomised phase II study of carboplatin and vinorelbine versus carboplatin and etoposide in good performance status small cell lung cancer patients presenting with adverse prognostic factors. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Small cell lung cancer |
| Intervention | 1. Chemotherapy with carboplatin and vinorelbine 2. Chemotherapy with carboplatin and etoposide Added July 2008: trial stopped because of poor recruitment |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Toxicity |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 08/04/2006 |
| Reason abandoned (if study stopped) | Insufficient personel |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Elderly patients >65 years with good prognosis and Eastern Cooperative Oncology Group (ECOG) p/s <2 2. Confirmed small cell lung cancer not considered eligible for aggressive multimodality therapy |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 08/04/2002 |
| Date of final enrolment | 08/04/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Clatterbridge Centre for Oncology
Wirral
CH63 4JY
United Kingdom
CH63 4JY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
