| Source of record | UK Trials |
| ISRCTN | ISRCTN67216192 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | TR8SCLC |
| Public title | A randomised study of timing of thoracic irradiation in small cell lung cancer |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Lung (small cell) |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. Patients with pleural effusions are not eligible
9. Patients with evidence of extensive disease are not eligible
10. No prior treatment with radiotherapy or chemotherapy
11. 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 31/01/2002 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN67216192 |
| Date last extracted from ISRCTN register | 17/04/2008 |
