Randomised trial in newly diagnosed Hodgkin's disease: evaluation of drug scheduling (alternating LOPP/EVAP versus LOPP/EVA hybrid) and consolidation radiotherapy

ISRCTN	ISRCTN97767916
DOI	https://doi.org/10.1186/ISRCTN97767916
Secondary identifying numbers	BNLI2

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

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Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomised trial in newly diagnosed Hodgkin's disease: evaluation of drug scheduling (alternating LOPP/EVAP versus LOPP/EVA hybrid) and consolidation radiotherapy
Study objectives	Evaluation of drug scheduling (alternating LOPP/EVAP versus LOPP/EVA hybrid) and consolidation radiotherapy
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Hodgkin's lymphoma
Intervention	1. Regimen A: Chemotherapy, chlorambucil vincristine, procarbazine and prednisolone (LOPP) alternating every 28 days with etoposide, vinblastine, adriamycin and prednisolone (EVAP). A course of chemotherapy is given every 28 days for a minimum of six cycles. 2. Regimen B: Chemotherapy, chlorambucil, vincristine, procarbazine and prednisolone, etoposide, vinblastine, adriamycin (LOPP/EVA) repeated every 28 days for a minimum of six cycles.
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1999
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Aged over 15 years 2. Stage IB, IIB, III or IV Hodgkin's Disease. 3. Histologically confirmed Hodgkin's lymphoma 4. Free from any potentially life threatening disease other than Hodgkin's Disease 5. Lymphangiography or Computed Tomography (CT) scan of the abdomen 6. No previous treatment except as an emergency measure
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1999
Date of final enrolment	31/12/2005

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Lymphoma Research Trust

No information available

Cancer Research UK
Private sector organisation / Other non-profit organizations

Lisa Lear Fund

No information available

Isle of Man Anti-Cancer Association

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan