A Phase III Randomised comparison of Gemcitabine/Carboplatin with Cisplatin/Etoposide in Small Cell Lung Cancer
ISRCTN | ISRCTN39679215 |
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DOI | https://doi.org/10.1186/ISRCTN39679215 |
Secondary identifying numbers | Study 10 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 29/10/2021
- 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 | Not Specified |
Scientific title | A Phase III Randomised comparison of Gemcitabine/Carboplatin with Cisplatin/Etoposide in Small Cell Lung Cancer |
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) cancer |
Intervention | 1. GC Arm: 3-weekly regimen (6 cycles) Gemcitabine 1200 mg/m(2) IV (Day 1 and 8) Carboplatin (AUC 5) Dose in mg calculated according to the formula: Dose = Target area under curve x (creatinine clearance + 25) IV (Day1) 2. PE Arm: 3-weekly regime (6 cycles): Cisplatin 60 mg/m2 IV Day 1 Etoposide 120 mg/m2 IV (Day 1) and 100 mg bd po (days 2 and 3) |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | Cancer drugs |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/1996 |
Completion date | 31/10/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Not provided at time of registration |
Total final enrolment | 241 |
Key inclusion criteria | 1. Histologically or cytologically proven small cell anaplastic carcinoma of the lung 2. Extensive stage disease or limited stage but locally advanced or limited stage with poor prognostic factors 3. Measurable or evaluable disease 4. Adequate renal function for chemotherapy 5. Age 18 years or above 6. Adequate contraception for women of child bearing potential 7. Written informed consent |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/01/1996 |
Date of final enrolment | 31/10/2001 |
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
NCRI CSG and London Lung Cancer Group (UK)
Research organisation
Research organisation
-
London
-
United Kingdom
https://ror.org/02mp0vf47 |
Funders
Funder type
Research organisation
NCRI CSG and London Lung Cancer Group (UK)
No information available
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 | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/06/2001 | Yes | No | |
Plain English results | 08/09/2009 | 29/10/2021 | No | Yes |
Editorial Notes
29/10/2021: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.