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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25539730
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26834240