Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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

Sponsor information

Organisation

NHS R&D 'Time-Limited' National Programmes

Sponsor details

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

Sponsor type

Government

Website

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

Publication citations

Additional files

Editorial Notes

30/11/2015: Publication references added.