Oral chemotherapy versus intravenous chemotherapy in limited or extensive small cell lung cancer

ISRCTN ISRCTN81334858
DOI https://doi.org/10.1186/ISRCTN81334858
Secondary identifying numbers LU309
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
18/09/2017
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

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
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleOral chemotherapy versus intravenous chemotherapy in limited or extensive small cell lung cancer: a randomised controlled trial
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLung (small cell)
Intervention1. Oral Regimen: Oral etoposide and cyclophosphamide given over 5 days every 3 weeks.
2. Intravenous Regimen: Intravenous combination of three or more drugs routinely used in the centre with the usual dose reduction. A standard alternative is adriamycin, cyclophosphamide and vincristine (VAC) repeated every 3 weeks.
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 date31/12/2000
Reason abandoned (if study stopped)Objectives no longer viable

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Histologically or cytologically proven small cell lung cancer
2. No previous or concurrent malignancy
3. Fit to receive chemotherapy
4. No prior chemotherapy or radiotherapy
5. No biochemical or haematological abnormalities which would preclude chemotherapy
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1995
Date of final enrolment31/12/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

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?
Interim results article interim results 31/08/1996 Yes No

Editorial Notes

18/09/2017: internal review.