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

ISRCTN	ISRCTN92669260
DOI	https://doi.org/10.1186/ISRCTN92669260
Protocol serial number	TR7SCLC
Sponsor	UK Co-ordinating Committee for Cancer Research (UKCCCR)
Funder	Cancer organisations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

- -
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Cyclophosphamide, adriamycin, vincristine, etoposide, cisplatin
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2000
Date of final enrolment	31/12/2005

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes