Condition category
Cancer
Date applied
12/09/2003
Date assigned
29/10/2003
Last edited
06/05/2016
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

HD13 for early stage Hodgkin's disease: quality assurance protocol for reduction of toxicity in the first-line treatment of early stage Hodgkin's Disease (HD)

Acronym

HD13

Study hypothesis

Reduction of toxicity through deescalation of chemotherapy while maintaining high Freedom From Treatment Failure (FFTF) and Overall Survival rates.

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

Patient information material can be found at http://www.lymphome.de/en/Groups/GHSG/Protocols/HD13/Patient-Information.pdf

Condition

Hodgkin's disease

Intervention

Arm A: 2 x Doxorubicin, Bleomycin, Vinblastine, Dacarbazine (ABVD) and 30 Gy Involved Field Radiotherapy (IF-RT)
Arm B: 2 x Doxorubicin, Bleomycin, Vinblastine (ABV) and 30 Gy IF-RT
Arm C: 2 x Doxorubicin, Vinblastine, Dacarbazine (AVD) and 30 Gy IF-RT
Arm D: 2 x Doxorubicin, Vinblastine (AV) and 30 Gy IF-RT

Intervention type

Drug

Phase

Not Applicable

Drug names

Doxorubicin, Bleomycin, Vinblastine, Dacarbazine (ABVD)

Primary outcome measures

Freedom From Treatment Failure (FFTF) .

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed Hodgkin's disease
2. Stages IA (not lympocyte predominant HD), IB, IIA, and IIB without 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) (greater than or equal to 50 mm; greater than or equal to 30 mm with B symptoms)
2.4. Three or more involved lymph node areas
3. No prior therapy for Hodgkin's disease
4. Aged 18 - 75 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

1250

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 Immunodeficiency 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. Pregnancy or breastfeeding
7. World Health Organization (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

01/01/2003

Recruitment end date

01/01/2008

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

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25539730
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26834240

Publication citations

Additional files

Editorial Notes

06/05/2016: Publication reference added.