Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
23/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

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 measures

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

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

http://www.cancer.org.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes