Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003364
Protocol/serial number
TR8SCLC
Study information
Scientific title
A randomised study of timing of thoracic irradiation in small cell lung cancer
Acronym
Study hypothesis
Not provided at time of registration
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
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1989
Overall trial end date
31/01/2002
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Patients with pleural effusions are not eligible
2. Patients with evidence of extensive disease are not eligible
Recruitment start date
01/01/1989
Recruitment end date
31/01/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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. 20016 results in https://www.ncbi.nlm.nih.gov/pubmed/16921033 (added 25/01/2019)