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

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

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"	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 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