The Big Lung Trial: Does Short-Term Chemotherapy Improve the Survival of Patients with Non-Small Cell Lung Cancer (NSCLC)

ISRCTN	ISRCTN57155593
DOI	https://doi.org/10.1186/ISRCTN57155593
Secondary identifying numbers	BLT

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Dr - -
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	The Big Lung Trial: Does Short-Term Chemotherapy Improve the Survival of Patients with Non-Small Cell Lung Cancer (NSCLC)
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)
Intervention	1. CHEMOTHERAPY REGIMEN: Three cycles of one of the following regimens should be given: Cisplatin plus vindesine; Mitomycin C, ifosfamide and cisplatin; Mitomycin C, vinblastine and cisplatin; Navelbine and Cisplatin. Chemotherapy may be given as follows: A. Adjuvant Chemotherapy Option: Chemotherapy to start as soon as possible after surgery or following completion of radical radiotherapy. B. Neo-adjuvant Option: Chemotherapy should start as soon as possible. C. Supportive Care Group: Chemotherapy should start as soon as possible after randomisation and be given concurrently with supportive care. 2. CONTROL REGIMEN: No chemotherapy.
Intervention type	Other
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	31/12/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Fulfil local criteria for diagnosis of NSCLC 2. Be fit to receive, and have no clear contraindications to chemotherapy 3. Patients randomised to adjuvant chemotherapy should be able to start chemotherapy within 10 weeks of completion of surgery or radical radiotherapy 4. No concurrent malignancy, or any history of malignancy, other than non-melanomatous skin cancer within the last 3 years
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1995
Date of final enrolment	31/12/2005

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

NHS R&D 'Time-Limited' National Programmes
Government

Commissioning Units
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom

"ROR"	https://ror.org/02wnqcb97

Government

NHS Research and Development Programme (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	Peer reviewed?	Patient-facing?
Plain English results			No	Yes
Results article	results	01/07/2004	Yes	No
Results article	results	01/05/2005	Yes	No
Results article	results	20/10/2005	Yes	No

26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
30/11/2015: Publication references added.