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

ISRCTN ISRCTN39643421
DOI https://doi.org/10.1186/ISRCTN39643421
Secondary identifying numbers LY/SCT
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
08/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
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

Contact information

- - -
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleTrial of Short Course Therapy in Elderly Patients with High Grade Non-Hodgkin's Lymphoma
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLymphoma (non-Hodgkin's)
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot 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 measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2000
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupSenior
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/2000
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government

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

ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Research organisation

Cancer organisations (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan