Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
24/02/2015
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

Protocol/serial number

TR7SCLC

Study information

Scientific title

Randomised trial of two schedules of chemotherapy of the same dose/time intensity in untreated small cell lung cancer (SCLC) of poor prognosis

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

1. Standard Regimen:
Multi-drug chemotherapy, cyclophosphamide, adriamycin and vincristine alternating every 21 days with etoposide and cisplatin. A total of six courses, three with each drug combination.

2. Low Dose/High Frequency Regimen:
Multi-drug chemotherapy, etoposide and cisplatin alternating every 10/11 days with cyclophosphamide, adriamycin and vincristine. A total of twelve courses, six with each drug combination. This schedule uses the same drugs as in the standard regimen but at half the dose and twice the frequency with the same intended overall dose intensity.

Intervention type

Drug

Phase

Not Applicable

Drug names

Cyclophosphamide, adriamycin, vincristine, etoposide, cisplatin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically or cytologically proven small cell carcinoma of the lung
2. Aged 75 or under
3. Extensive disease and poor prognosis, ie Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3 and/or alkaline phosphatase >1.5 upper limit of normal range
4. Adequate renal function
5. No previous malignancy, except non melanomatous skin cancer in the preceding 3 years
6. No previous chemotherapy or radiotherapy, except for emergency radiotherapy for superior vena cava obstruction
7. No medical contraindications to treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2000

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

UK Co-ordinating Committee for Cancer Research (UKCCCR)

Sponsor details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Research organisation

Funder name

Cancer organisations

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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