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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 10.1186/ISRCTN32443041
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym HD15
Serial number at source N/A
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Germany
Disease/condition/study domain Hodgkin's disease
Participants - 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
Participants - 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)
Anticipated start date 01/01/2003
Anticipated end date 01/01/2008
Status of trial Completed
Patient information material Patient information sheet can be found at http://www.lymphome.de/en/Groups/GHSG/Protocols/HD15/Patient-Information.pdf
Target number of participants 400
Interventions 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
Primary outcome measure(s) Freedom from treatment failure (FFTF).
Secondary outcome measure(s) Impact of erythropoetin on quality of life and prognostic significance of FDG-PET.
Sources of funding Deutsche Krebshilfe (Germany)
Trial website
Publications 2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18757777
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22480758
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24799482
Contact name Prof  Volker  Diehl
  Address German Hodgkin's Lymphoma Study Group,
Herderstr. 52-54
  City/town Cologne
  Zip/Postcode 50924
  Country Germany
  Tel +49/221/478-3557 (-3558)
  Fax +49/221/478-6311
  Email dhsg@biometrie.uni-koeln.de
Sponsor German Hodgkin's Lymphoma Study Group (Germany)
  Address Herderstr. 52-54
  City/town Cologne
  Zip/Postcode 50924
  Country Germany
  Tel +49 (0)221 478-3557 (-3558)
  Fax +49 (0)221 478-6311
  Email dhsg@biometrie.uni-koeln.de
Date applied 11/09/2003
Last edited 07/10/2014
Date ISRCTN assigned 29/10/2003
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