Condition category
Cancer
Date applied
12/09/2003
Date assigned
29/10/2003
Last edited
12/08/2013
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

Prof Volker Diehl

ORCID ID

Contact details

German Hodgkin's Lymphoma Study Group
Herderstr. 52-54
Cologne
50924
Germany
+49 (0)221 478 3557 (3558)
dhsg@biometrie.uni-koeln.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

HD14

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised open labed active controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hodgkin's disease

Intervention

Primary objective: to increase effectiveness Arm A: 4 x ABVD + 30 Gy involved field radiotherapy
Arm B: 2 x BEACOPPescalated + 2 x ABVD + 30 Gy involved field radiotherapy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Freedom From Treatment Failure [FFTF]

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2003

Overall trial end date

01/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed Hodgkin's disease
2. Stages IA, IB, and IIA with one or more of the following risk factors:
2.1. Massive mediastinal involvement (tumour one third or more of the maximum intrathoracic diameter)
2.2. Extranodal involvement
2.3. High erythrocyte sedimentation rate (ESR) (more than or equal to 50 mm; more than or equal to 30 mm in patients with B symptoms)
2.4. Three or more involved lymph node areas; stage IIB and high ESR (more than or equal to 30 mm) and/or three or more involved lymph node areas
3. No prior therapy for Hodgkin's disease
4. Age: 18 to 60 years
5. No major organ dysfunction
6. Life expectancy more than three months
7. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Incomplete staging
2. Major organ dysfunction (Chronic Obstructive Pulmonary Disease [COPD] with respiratory insufficiency, symptomatic Coronary Heart Disease [CHD], cardiomyopathy or heart failure [ejection fraction less than 50%], severe hypertension, non-treatable infections, white blood count less than 3000/mm^3 or platelets less than 100,000/mm^3, creatinine clearance less than 60 ml/min, bilirubin more than 2 mg/dl, Glutamic-Oxaloacetic Transaminase [GOT]/ASpartate aminoTransferase [AST] more than 100 U/l, Glutamic-Pyruvic Transaminase [GPT]/ALanine aminoTransferase [ALT] more than 100 U/l, Human Immunodeficieny Virus [HIV]-infection)
3. Composite lymphoma
4. Prior chemotherapy or radiotherapy
5. Any history of another malignancy in the last five years (except for cervical carcinoma in situ and fully resected melanoma TNMpT1)
6. Pregnant or lacating women
7. World Health Organisation (WHO) performance status more than two
8. Long term use of corticosteroids (e.g. for arthritis) or antineoplastic substances (e.g. methotrexate)
9. Expected non compliance
10. Current therapy for epilepsy
11. Intolerabilities against study drugs
12. Inability to give truly informed consent

Recruitment start date

01/10/2003

Recruitment end date

01/10/2004

Locations

Countries of recruitment

Germany

Trial participating centre

German Hodgkin's Lymphoma Study Group
Cologne
50924
Germany

Sponsor information

Organisation

German Hodgkin's Lymphoma Study Group (Germany)

Sponsor details

Herderstr. 52-54
Cologne
50924
Germany
+49 (0)221 478 3557 (3558)
dhsg@biometrie.uni-koeln.de

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

German Cancer Aid (Deutsche Krebshilfe) (Germany)

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