Randomised trial of neo-adjuvant therapy in patients with stage IIIA non small cell lung cancer

ISRCTN ISRCTN54157750
DOI https://doi.org/10.1186/ISRCTN54157750
Protocol serial number LU20
Sponsor Medical Research Council (MRC) (UK)
Funder Medical Research Council (MRC) (UK)
Submission date
28/02/2001
Registration date
28/02/2001
Last edited
20/02/2020
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

Not provided at time of registration

Contact information

Dr Danielle Andrews
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Email abc@123.com

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title-
Study objectivesTo compare in patients with stage IIIA non small cell lung cancer a policy of standard therapy with thoracic radiotherapy versus a policy of chemotherapy followed, if feasible, by surgery
Ethics approval(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedCancer
Intervention1. One group receives standard therapy with thoracic radiotherapy
2. The other group receives chemotherapy followed, if feasible, by surgery
Intervention typeOther
Primary outcome measure(s)

1. Survival time
2. Quality of life

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/05/1999

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexAll
Target sample size at registration350
Total final enrolment48
Key inclusion criteria1. No previous treatment for the current lung cancer
2. Either sex
3. World Health Organisation (WHO) 0-2, T3N1M0 or T1-3N2M0 stage
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/1995
Date of final enrolment01/05/1999

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2005 20/02/2020 Yes No
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

20/02/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
3. The trial website was added.