A randomised study of oral versus intravenous chemotherapy in poor prognosis small cell lung cancer (SCLC)

ISRCTN	ISRCTN73797340
DOI	https://doi.org/10.1186/ISRCTN73797340
Protocol serial number	TR9SCLC
Sponsor	UK Co-ordinating Committee for Cancer Research (UKCCCR)
Funder	Not provided at time of registration

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

Dr - -
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
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)
Intervention	1. Regimen A: Chemotherapy, oral etoposide repeated every 3 weeks for six courses. 2. Regimen B: Multi-drug chemotherapy, CAV (cyclophosphamide, adriamycin, vincristine) alternating every 3 weeks with PE (etoposide, cisplatin). A total of six courses, three with each drug combination.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2000
Reason abandoned (if study stopped)	Objectives no longer viable

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Key inclusion criteria	1. Histologically or cytologically proven SCLC 2. Patients with extensive disease and poor prognosis, i.e., Eastern Cooperative Oncology Group (ECOG) performance 2 or 3 or alkaline phosphatase >1.5 upper limit normal range 3. Patients 75 years and over, whatever stage of disease, deemed fit for randomisation 4. No previous malignancy, except non-melanomatous skin cancer in the preceding 3 years 5. No medical contraindications to treatment 6. Adequate renal function
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1997
Date of final enrolment	31/12/2000

UKCCCR Register Co-ordinator

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?
Results article	results	31/08/1996		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes