Trial of Short Course Therapy in Elderly Patients with High Grade Non-Hodgkin's Lymphoma

ISRCTN	ISRCTN39643421
DOI	https://doi.org/10.1186/ISRCTN39643421
Protocol serial number	LY/SCT
Sponsor	UK Co-ordinating Committee for Cancer Research (UKCCCR)
Funder	Cancer organisations (UK)

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
Scientific title	Trial of Short Course Therapy in Elderly Patients with High Grade Non-Hodgkin's Lymphoma
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Lymphoma (non-Hodgkin's)
Intervention	1. PACEBO Regimen: Adriamycin, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone and septin, cycle to be repeated every 14 days for four cycles. 2. PMitCEBO Regimen: Mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone and septin, cycle to be repeated every 14 days for four cycles.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	PACEBO Regimen: Adriamycin, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone and septin PMitCEBO Regimen: Mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone and septin
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	Senior
Sex	Not Specified
Key inclusion criteria	1. Aged 60 to 85 years 2. Newly presenting high grade lymphoma presenting as: 2.1 Follicular lymphoma 2.2 Diffuse large cell lymphoma including immunoblastic 2.3 Diffuse mixed cell lymphoma - Lymphoblastic and Burkitt's lymphoma are excluded 3. Stage IB-IV 4. Patients must be free from any other irreversible medical condition that would drastically limit their lifespan or prohibit the use of combination chemotherapy
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