Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LY/SCT
Study information
Scientific title
Trial of Short Course Therapy in Elderly Patients with High Grade Non-Hodgkin's Lymphoma
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
Condition
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 names
PACEBO Regimen: Adriamycin, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone and septin
PMitCEBO Regimen: Mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone and septin
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. 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
Participant type
Patient
Age group
Senior
Gender
Not Specified
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
Funders
Funder type
Research organisation
Funder name
Cancer organisations (UK)
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