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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised study of timing of thoracic irradiation in small cell lung cancer
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLung (small cell) cancer
InterventionAll 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1989
Completion date31/01/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteria1. Patients with pleural effusions are not eligible
2. Patients with evidence of extensive disease are not eligible
Date of first enrolment01/01/1989
Date of final enrolment31/01/2002

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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