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
Secondary identifying numbers	Study 11

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

http://www.cancerresearchuk.org/cancer-help/trials/chemotherapy-in-nonsmall-cell-lung-cancer-gemcitabine-and-carboplatin-compared-to-mic

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Gemcitabine/Carboplatin with Mitomycin, Ifosfamide and Cisplatin
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1995
Completion date	31/08/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Not provided at time of registration
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

England
United Kingdom

Study participating centre

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Sponsor information

London Lung Cancer Group (UK)
Research organisation

-
London
-
United Kingdom

Email	none@provided.com

Funders

Funder type

Research organisation

London Lung Cancer Group (UK)

No information available

Results and Publications

Intention to publish date
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	01/01/2005		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.