HD15 for advanced stage Hodgkin's disease: Quality assurance protocol for reduction of toxicity and the prognostic relevance of fluorodeoxyglucose-positron-emission tomography (FDG-PET) in the first-line treatment of advanced stage Hodgkin's disease
| ISRCTN | ISRCTN32443041 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32443041 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/09/2003
- Registration date
- 29/10/2003
- Last edited
- 07/10/2014
- 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 | +49/221/478-3557 (-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 sheet can be found at http://www.lymphome.de/en/Groups/GHSG/Protocols/HD15/Patient-Information.pdf |
| Scientific title | |
| Study acronym | HD15 |
| Study objectives | Primary aim: Reduction of toxicity, de-escalation of chemotherapy while maintaining high freedom from treatment failure (FFTF) and overall survival (OS) rates. Secondary aims: Assess the influence of erythropoietin on the quality of life and the effect of FDG-PET on prognosis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Hodgkin's disease |
| Intervention | In this trial three combinations of chemotherapy are compared in a randomised, controlled trial (open-label). In addition patients in every arm are randomly assigned to receive erythropoetin or placebo (double-blind). Restaging with PET is not allocated in a randomised fashion: Arm A: 1. 8 x erythropoietin, cyclophosphamide, adriamycin, etoposide, vincristine, bleomycin, procarbazine (BEACOPP) (escalated) 2. Erythropoetin/placebo 3. 30 Gy involved field radiotherapy if partial remission after chemotherapy and PET is positive Arm B: 1. 6 x BEACOPP (escalated) 2. Erythropoetin/placebo 3. 30 Gy involved field radiotherapy if partial remission after chemotherapy and PET is positive Arm C: 1. 8 x BEACOPP-14 2. Erythropoetin/placebo 3. 30 Gy involved field radiotherapy if partial remission after chemotherapy and PET is positive |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Erythropoietin, cyclophosphamide, adriamycin, etoposide, vincristine, bleomycin, procarbazine (BEACOPP) |
| Primary outcome measure | Freedom from treatment failure (FFTF). |
| Secondary outcome measures | Impact of erythropoetin on quality of life and prognostic significance of FDG-PET. |
| 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 | 400 |
| Key inclusion criteria | Chemotherapy: 1. Histologically confirmed Hodgkin's disease 2. Stage IIB and massive mediastinal involvement (tumour one third or more of the maximum intrathoracic diameter) and/or extranodal involvement, stage III, and stage IV 3. No prior therapy for Hodgkin's disease 4. Age: 18 - 60 years 5. No major organ dysfunction 6. Life expectancy greater than 3 months 7. Written informed consent PET: 1. Chemotherapy according to the HD15-protocol 2. Response to chemotherapy 3. Partial response with residual disease of at least 2.5 cm maximum diameter |
| Key exclusion criteria | Chemotherapy: 1. Incomplete staging 2. Major organ dysfunction: 2.1. Chronic obstructive pulmonary disease (COPD) with respiratory insufficiency 2.2. Symptomatic coronary heart disease (CHD) 2.3. Cardiomyopathy or heart failure (ejection fraction less than 50%) 2.4. Severe hypertension 2.5. Non-treatable infections 2.6. White blood count less than 3000/mm^3 or platelets less than 100,000/mm^3 if not related to bone marrow involvement 2.7. Creatinine clearance less than 60 ml/min 2.8. Bilirubin greater than 2 mg/dl if not related to Hodgkin's disease 2.9. Glutamic oxaloacetic transaminase (GOT)/aspartate aminotransferase (AST) greater than 100 U/l if not related to Hodgkin's disease 2.10. Glutamic pyruvic transaminase (GPT)/alanine aminotransferase (ALT) greater than 100 U/l if not related to Hodgkin's disease 2.11. Human immunodeficiency virus (HIV)-infection 3. Composite lymphoma 4. Prior chemotherapy or radiotherapy 5. Any history of another malignancy in the last 5 years (except for cervical carcinoma in situ and fully resected melanoma TNMpT1) 6. Pregnancy or breastfeeding 7. World Health Organisation (WHO) performance status greater than 2 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 PET: 1. Diabetes mellitus 2. Elevated blood glucose (greater than 130 mg/dl) 3. Massive bone involvement (endangering stability) |
| 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
Charity
Deutsche Krebshilfe (Germany)
No information available
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 | 15/11/2008 | Yes | No | |
| Results article | results | 12/05/2012 | Yes | No | |
| Results article | results | 10/06/2014 | Yes | No |
