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ISRCTN
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ISRCTN67216192
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ClinicalTrials.gov identifier
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Public title
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A randomised study of timing of thoracic irradiation in small cell lung cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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TR8SCLC
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Lung (small cell) cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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1. Patients with pleural effusions are not eligible
2. Patients with evidence of extensive disease are not eligible
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Anticipated start date
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01/01/1989
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Anticipated end date
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31/01/2002
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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28/05/2008
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Date ISRCTN assigned
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01/07/2001
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