Plain English Summary
http://cancerhelp.cancerresearchuk.org/trials/blt-the-big-lung-trial2
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BLT
Study information
Scientific title
The Big Lung Trial: Does Short-Term Chemotherapy Improve the Survival of Patients with Non-Small Cell Lung Cancer (NSCLC)
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1995
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1995
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Funders
Funder type
Government
Funder name
NHS Research and Development Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15200998
2. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16094738
3. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16157935