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

Conditions

Hodgkin's disease Cancer Hodgkin's disease

Bröckelmann PJ, Müller H, Casasnovas O, Hutchings M, von Tresckow B, Jürgens M, McCall SJ, Morschhauser F, Fuchs M, Borchmann P, Moskowitz CH, Engert A.

2017-06-0158 citations

10.1093/annonc/mdx072

Kreissl S, Mueller H, Goergen H, Mayer A, Brillant C, Behringer K, Halbsguth TV, Hitz F, Soekler M, Shonukan O, Rueffer JU, Flechtner HH, Fuchs M, Diehl V, Engert A, Borchmann P, German Hodgkin Study Group.

2016-09-0672 citations

10.1016/s1470-2045(16)30093-6

Reduced-intensity chemotherapy and PET-guided radiotherapy in patients with advanced stage Hodgkin's lymphoma (HD15 trial): a randomised, open-label, phase 3 non-inferiority trial.

Engert A, Haverkamp H, Kobe C, Markova J, Renner C, Ho A, Zijlstra J, Král Z, Fuchs M, Hallek M, Kanz L, Döhner H, Dörken B, Engel N, Topp M, Klutmann S, Amthauer H, Bockisch A, Kluge R, Kratochwil C, Schober O, Greil R, Andreesen R, Kneba M, Pfreundschuh M, Stein H, Eich HT, Müller RP, Dietlein M, Borchmann P, Diehl V, German Hodgkin Study Group, Swiss Group for Clinical Cancer Research, Arbeitsgemeinschaft Medikamentöse Tumortherapie.

2012-04-04394 citations

10.1016/s0140-6736(11)61940-5

Positron emission tomography has a high negative predictive value for progression or early relapse for patients with residual disease after first-line chemotherapy in advanced-stage Hodgkin lymphoma.

Kobe C, Dietlein M, Franklin J, Markova J, Lohri A, Amthauer H, Klutmann S, Knapp WH, Zijlstra JM, Bockisch A, Weckesser M, Lorenz R, Schreckenberger M, Bares R, Eich HT, Mueller RP, Fuchs M, Borchmann P, Schicha H, Diehl V, Engert A.

2008-08-29124 citations

10.1182/blood-2008-06-155820

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 placeb

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Freedom from treatment failure (FFTF).	—

Secondary

Measure	Time frame
Impact of erythropoetin on quality of life and prognostic significance of FDG-PET.	—

Countries

Germany

Outcome results

None listed