A randomised study of Gemcitabine with Carboplatin versus Mitomycin, Vinblastine and Cisplatin (MVP) or Mitomycin C, Ifosfamide and Cisplatin (MIC) chemotherapy in inoperable advanced stage non-small cell lung cancer (NSCLC)

ISRCTN	ISRCTN41486350
DOI	https://doi.org/10.1186/ISRCTN41486350
Secondary identifying numbers	N0063072220

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Dr N Thatcher
Scientific

Medical Oncology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom

Phone	+44 (0)161 446 3749

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	The aim of the study is to compare the response rate, time to progression and the survival of patients randomised either to receive Gemcitabine with Carboplatin or MVP/MIC.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Non small cell lung cancer
Intervention	Randomised, phase III, comparative trial.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Gemcitabine with Carboplatin versus Mitomycin, Vinblastine and Cisplatin (MVP) or Mitomycin C, Ifosfamide and Cisplatin (MIC)
Primary outcome measure	survival
Secondary outcome measures	1. time to progression 2. response rates 3. evaluation of toxicity 4. disease-related symptoms 5. World Health Organization performance status 6. quality of life
Overall study start date	01/04/1998
Completion date	01/11/2001

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	660 targeted, 372 recruited
Key inclusion criteria	1. NHS patients with pathologically confirmed NSCLC, stage IIIa, IIIb, or IV 2. ineligible for curative radical radiotherapy or surgery after discussion in a multidisciplinary team setting comprised of at least a chest physician, a surgeon, and an oncologist 3. no previous chemotherapy 4. age older than 18 years 5. life expectancy of at least 12 weeks 6. adequate bone marrow reserve (leukocyte count > 3 × 10^9/L, platelet count > 100 × 10^9/L, and hemoglobin > 100 g/dL) 7. creatinine clearance > 60 mL/minute 8. adequate birth-control measures
Key exclusion criteria	1. active infection 2. bony disease as the only measurable disease 3. prior radiotherapy to the sole site of assessable disease 4. inadequate renal or hepatic function 5. serious comorbidity 6. other malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) 7. peripheral neuropathy Grade > 2 8. significant neurologic or psychiatric disorder 9. symptomatic brain metastases
Date of first enrolment	01/04/1998
Date of final enrolment	01/11/2001

Medical Oncology

Manchester
M20 4BX
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Hospital/treatment centre

Christie Hospital NHS Trust (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2003		Yes	No