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
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
26/10/2018
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://cancerhelp.cancerresearchuk.org/trials/blt-the-big-lung-trial2

Contact information

Dr - -
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleThe Big Lung Trial: Does Short-Term Chemotherapy Improve the Survival of Patients with Non-Small Cell Lung Cancer (NSCLC)
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLung (non-small cell)
Intervention1. 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1995
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/1995
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

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

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

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

Funders

Funder type

Government

NHS Research and Development Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added 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

Editorial Notes

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