The Big Lung Trial: Does Short-Term Chemotherapy Improve the Survival of Patients with Non-Small Cell Lung Cancer (NSCLC)
ISRCTN | ISRCTN57155593 |
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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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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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 |
Eligibility
Participant type(s) | Patient |
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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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
NHS R&D 'Time-Limited' National Programmes
Government
Government
Commissioning Units
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom
https://ror.org/02wnqcb97 |
Funders
Funder type
Government
NHS Research and Development Programme (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |
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.