A Phase III randomised comparison of Gemcitabine/Carboplatin with Mitomycin, Ifosfamide and Cisplatin in non-small cell lung cancer
| ISRCTN | ISRCTN52253218 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52253218 |
| Protocol serial number | Study 11 |
| Sponsor | London Lung Cancer Group (UK) |
| Funder | London Lung Cancer Group (UK) |
- 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
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 |
| Scientific title | A Phase III randomised comparison of Gemcitabine/Carboplatin with Mitomycin, Ifosfamide and Cisplatin in non-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 (non-small cell) cancer |
| Intervention | 1. GC Arm: 3-weekly regimen. Gemcitabine 1200 mg/m2 IV (Day 1 and 8) Carboplatin (AUC 5). Dose calculated according to the formula: Dose = Target area under curve x (creatinine clearance + 25) IV (Day 1) 2. MIC 3-Weekly regimen: Mitomycin 6 mg/m2 IV (Day 1) Ifosfamide 3 g/m2 IV (Day 1) Cisplatin 50 mg/m2 IV (Day 1) |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Gemcitabine/Carboplatin with Mitomycin, Ifosfamide and Cisplatin |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Total final enrolment | 422 |
| Key inclusion criteria | 1. Histologically or cytologically proven non-small cell carcinoma of the lung 2. Stage IIIb or IV disease 3. Measurable or evaluable disease 4. Adequate renal function (Ethylene diamine tetraacetic acid [EDTA] Clearance >60 ml/min) 5. Age 18 or over 6. Adequate contraception in females of child-bearing potential 7. Written informed consent 8. No prior radiotherapy or chemotherapy 9. Not less than 8 weeks life expectancy 10. No history of prior malignancy (except non-melanomatous skin tumour or has been without evidence of disease for 3 years or more) 11. White cell count >3000/ml Platelet count >100,000/ml Haemaglobin >10.0 g.dL 12. No symptomatic brain metastases |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1995 |
| Date of final enrolment | 31/08/2001 |
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 | 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 | 01/01/2005 | 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.
