Phase II comparison of accelerated twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with etoposide and cisplatin
| ISRCTN | ISRCTN54145633 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54145633 |
| Secondary identifying numbers | N0063115998 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 04/10/2012
- 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 C Faivre-Finn
Scientific
Scientific
Clinical Oncology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | This randomised phase II trial is aiming to assess the acute toxicity of twice-daily and once-daily concurrent chemo-radiotherapy. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | etoposide and cisplatin |
| Primary outcome measure | Acute toxicity (particularly grade III/IV oesophagitis). |
| Secondary outcome measures | 1. Overall survival 2. Response rates |
| Overall study start date | 01/09/2002 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 81 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Oncology
Manchester
M20 4BX
United Kingdom
M20 4BX
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Christie Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Results article | Yes | No |
