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) |
- 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
| 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 |
Eligibility
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |