Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
29/08/2007
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

HD305

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Lymphoma (Hodgkin's)

Intervention

Patients are divided into two cohorts based on risk factors and randomised to receive either standard treatment (radiation or combined modality therapy according to cohort assignment) or experimental treatment (ABVD):

1. STANDARD ARM:
A. Cohort 1: Radiotherapy only.
B. Cohort 2: Chemotherapy, adriamycin, bleomycin, vinblastine and decarbazine (ABVD) given intravenously on days 1 and 15 of a 28 day cycle. Two cycles of ABVD to be followed by radiotherapy.

2. EXPERIMENTAL ARM:
Chemotherapy, ABVD given intravenously on days 1 and 15 of a 28 day cycle. Patients initially receive two cycles of ABVD followed by restaging. Patients in complete remission receive a further two cycles of ABVD, and those patients assessed as achieving a partial remission and not demonstrating progressive disease receive a further four cycles of ABVD.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

22/07/1994

Overall trial end date

22/07/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven Hodgkin's disease
2. Ann Arbor stage I-IIa disease
3. Age between 16 and 70 years
4. No prior chemotherapy or radiotherapy
5. No prior or concurrent malignancies, except treated basal cell carcinoma
6. No cardiac disease
7. No stage Ia disease which is treatable with involved field only irradiation
8. No interabdominal disease
9. No B symptoms
10. No known Human Immunodeficiency Virus (HIV) infection

Participant type

Patient

Age group

Not Specified

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

22/07/1994

Recruitment end date

22/07/1999

Locations

Countries of recruitment

Canada

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)

Sponsor details

10 Alcorn Avenue
Suite 200
Toronto
M4V 3B1
Canada
+1 416 9617223
webadmin@cancer.ca

Sponsor type

Government

Website

http://www.ncic.cancer.ca

Funders

Funder type

Government

Funder name

National Cancer Institute of Canada Clinical Trials Group

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

Publication citations

Additional files

Editorial Notes