Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
01/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HO3001

Study information

Scientific title

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Lymphoma (Hodgkin's)

Intervention

FIRST RANDOMISATION: Patients are randomised to one of two chemotherapy regimens:
1. PA(B1)OE Regimen: Multi-drug chemotherapy with adriamycin, vincristine, prednisolone, etoposide and bleomycin (PA(B1)OE) repeated every 21 days for six to eight courses. Bleomycin is given for the first four course only.
2. Ch1VPP/PABLOE Regimen: Multi-drug chemotherapy with chlorambucil, procarbazine, prednisolone and vinblastine(CH1VPP) alternating with PA(B1)OE. The total cycle Ch1VPP/PA(B1)OE takes 7 weeks. A minimum of six, three each of Ch1VPP and PA(B1)OE, and a maximum of eight courses of chemotherapy to be given.

SECOND RANDOMISATION: Patients in complete remission following chemotherapy whose original presentation was with bulky (>5 cm) nodal disease are eligible for the second randomisation. Patients are randomised to one of two groups:
1. Group A: Radiotherapy 35-40 Gy given over 4 weeks.
2. Group B: No radiotherapy.

Intervention type

Drug

Phase

Not Specified

Drug names

Cancer drugs

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1990

Overall trial end date

01/04/1996

Reason abandoned

Eligibility

Participant inclusion criteria

1. Previously untreated and properly stage patients with Hodgkin's disease for whom chemotherapy is indicated, ie stage I and IIA (poor prognosis), IB, IIB, III and IV
2. Patients must be free from any irreversible medical condition that would drastically limit their life span or prohibit use of combination chemotherapy
3. Aged 15 to 69 years inclusive

Participant type

Patient

Age group

Adult

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

01/01/1990

Recruitment end date

01/04/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

British National Lymphoma Investigation (BNLI)

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

1. 2001 Results in http://www.ncbi.nlm.nih.gov/pubmed/11355937

Publication citations

  1. Results

    Hancock BW, Gregory WM, Cullen MH, Hudson GV, Burton A, Selby P, Maclennan KA, Jack A, Bessell EM, Smith P, Linch DC, , , ChlVPP alternating with PABlOE is superior to PABlOE alone in the initial treatment of advanced Hodgkin's disease: results of a British National Lymphoma Investigation/Central Lymphoma Group randomized controlled trial., Br. J. Cancer, 2001, 84, 10, 1293-1300, doi: 10.1054/bjoc.2001.1778.

Additional files

Editorial Notes