Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0063115998
Study information
Scientific title
Acronym
Study hypothesis
This randomised phase II trial is aiming to assess the acute toxicity of twice-daily and once-daily concurrent chemo-radiotherapy.
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
Hospitals
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer: Limited small-cell lung cancer
Intervention
Arm A: new total dose of 66 Gy given over 45 days once-daily concurrently with chemotherapy
Arm B: total 45 Gy given over 19 days twice-daily concurrently with chemotherapy
Intervention type
Drug
Phase
Phase II
Drug names
etoposide and cisplatin
Primary outcome measure
Acute toxicity (particularly grade III/IV oesophagitis).
Secondary outcome measures
1. Overall survival
2. Response rates
Overall trial start date
01/09/2002
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients who are ≤75 years of age with histologically proven small-cell lung cancer and fully meet the criteria will be approached for consent. 81 Patients in total will be recruited for the trial and 27 will be recruited to the standard arm and 54 to the experimental arm. 25 patients per year.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
81
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2002
Recruitment end date
31/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Oncology
Manchester
M20 4BX
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Christie Hospital NHS Trust (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
Basic results (scientific)
Publication list
1. 2008 results in http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=31597