HD14 for intermediate stage Hodgkin's disease: Quality assurance protocol to increase effectiveness in the first-line treatment of intermediate stage Hodgkin's disease
| ISRCTN | ISRCTN04761296 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04761296 |
| 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 | Multicentre randomised open labed active controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | HD14 for intermediate stage Hodgkin's disease: Quality assurance protocol to increase effectiveness in the first-line treatment of intermediate stage Hodgkin's disease |
| Study acronym | HD14 |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Freedom From Treatment Failure [FFTF] |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2003 |
| Completion date | 01/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| 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 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 |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 01/10/2004 |
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 | 01/09/2018 | Yes | No |
Editorial Notes
11/07/2018: Publication reference added.
