A randomised study of timing of thoracic irradiation in small cell lung cancer
ISRCTN | ISRCTN67216192 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN67216192 |
ClinicalTrials.gov number | NCT00003364 |
Secondary identifying numbers | TR8SCLC |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 28/10/2021
- 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 - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
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 | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | A randomised study of timing of thoracic irradiation in small cell lung cancer |
Study objectives | Not provided at time of registration |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Lung (small cell) cancer |
Intervention | All patients receive chemotherapy, CAV (cyclophosphamide, Adriamycin, vincristine) followed by EC (etoposide, cisplatin). This sequence is repeated three times. Each course is given at 3 week intervals. Patients are randomised to receive loco-regional irradiation as follows: 1. Early Radiotherapy Group: Loco-regional radiotherapy, 40 Gy given in fifteen fractions over 3 weeks with septrin prophylaxis. Radiotherapy to be given simultaneously with the first course of EC chemotherapy. 2. Late Radiotherapy Group: Loco-regional radiotherapy, 40 Gy given in fifteen fractions over 3 weeks with septrin prophylaxis. Radiotherapy to be given simultaneously with the third course of EC chemotherapy. If there is no evidence of progression following chemotherapy patients receive prophylactic brain irradiation (PCI), 25 Gy in ten fraction over 2 weeks. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/1989 |
Completion date | 31/01/2002 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Both |
Target number of participants | Not provided at time of registration |
Key inclusion criteria | 1. Histological or cytological proven small cell anaplastic carcinoma of the lung 2. Limited disease, that is, disease within the hemithorax, mediastinum or ipsilateral supraclavicular nodes 3. Measurable or evaluable disease 4. Fit to receive treatment 5. Aged <75 years 6. Life expectancy of more than 8 weeks 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-3 8. No prior treatment with radiotherapy or chemotherapy 9. No history of prior malignancy, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non melanoma skin tumour |
Key exclusion criteria | 1. Patients with pleural effusions are not eligible 2. Patients with evidence of extensive disease are not eligible |
Date of first enrolment | 01/01/1989 |
Date of final enrolment | 31/01/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
Phone | +44 (0)207 317 5186 |
---|---|
kate.law@cancer.org.uk | |
Website | http://www.cancer.org.uk |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
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 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 | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | 6 results | 20/08/2006 | 25/01/2019 | Yes | No |
Plain English results | 28/10/2021 | No | Yes |
Editorial Notes
28/10/2021: Cancer Research UK plain English results link added.
25/01/2019: Publication reference added