Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
04/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr C Faivre-Finn

ORCID ID

Contact details

Clinical Oncology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

1. 2008 results in http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=31597

Publication citations

Additional files

Editorial Notes