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)
| ISRCTN | ISRCTN63474366 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63474366 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/09/2003
- Registration date
- 29/10/2003
- Last edited
- 11/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Volker Diehl
Scientific
Scientific
German Hodgkin's Lymphoma Study Group
Herderstr. 52-54
Cologne
50924
Germany
| Phone | +49 (0)221 478-3557 (-3558) |
|---|---|
| dhsg@biometrie.uni-koeln.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information material can be found at http://www.lymphome.de/en/Groups/GHSG/Protocols/HD13/Patient-Information.pdf |
| 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) |
| Study acronym | HD13 |
| Study objectives | Reduction of toxicity through deescalation of chemotherapy while maintaining high Freedom From Treatment Failure (FFTF) and Overall Survival rates. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Doxorubicin, Bleomycin, Vinblastine, Dacarbazine (ABVD) |
| Primary outcome measure | Freedom From Treatment Failure (FFTF) . |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2003 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1250 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
German Hodgkin's Lymphoma Study Group
Cologne
50924
Germany
50924
Germany
Sponsor information
German Hodgkin's Lymphoma Study Group (Germany)
Research organisation
Research organisation
Herderstr. 52-54
Cologne
50924
Germany
| Phone | +49 (0)221 478-3557 (-3558) |
|---|---|
| dhsg@biometrie.uni-koeln.de |
Funders
Funder type
Research organisation
Deutsche Krebshilfe
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Stiftung Deutsche Krebshilfe, German Cancer Aid
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/04/2015 | Yes | No | |
| Results article | results | 05/05/2016 | Yes | No | |
| Results article | results | 01/09/2018 | Yes | No |
Editorial Notes
11/07/2018: Publication reference added.
06/05/2016: Publication reference added.
