Clinical trial NCT00265018: HD10 for Early Stages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hodgkin´s Lymphoma
Keywords: Hodgkin´s lymphoma
early stages
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2005-12-13
Enrollment: 1370
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.


Eligibility criteria: Inclusion Criteria:

* Hodgkin´s lymphoma (histologically proven)
* CS (PS) IA, IB, IIA,IIB without any of the following risk factors:

  1. bulky mediastinal mass (\> 1/3 maximum transverse thorax diameter)
  2. extranodal involvement
  3. ESR \> 50 (A), \> 30 (B-symptoms)
  4. 3 or more lymph node areas involved
* written informaed consent

Exclusion Criteria:

* Leukocytes \<3000/microl
* Platelets \<100000/microl
* Hodgkin´s Disease as "composite lymphoma"
* Activity index (WHO) \< grade 2

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Cologne
name: Volker Diehl, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engert A, Plutschow A, Eich HT, Lohri A, Dorken B, Borchmann P, Berger B, Greil R, Willborn KC, Wilhelm M, Debus J, Eble MJ, Sokler M, Ho A, Rank A, Ganser A, Trumper L, Bokemeyer C, Kirchner H, Schubert J, Kral Z, Fuchs M, Muller-Hermelink HK, Muller RP, Diehl V. Reduced treatment intensity in patients with early-stage Hodgkin's lymphoma. N Engl J Med. 2010 Aug 12;363(7):640-52. doi: 10.1056/NEJMoa1000067.
citation: Sasse S, Goergen H, Plutschow A, Boll B, Eichenauer DA, Fuchs M, Behringer K, Zijlstra JM, Greil R, Markova J, Topp MS, Meissner J, Neubauer A, Baues C, Engert A, Borchmann P, von Tresckow B. Outcome of Patients With Early-Stage Infradiaphragmatic Hodgkin Lymphoma: A Comprehensive Analysis From the German Hodgkin Study Group. J Clin Oncol. 2018 Sep 1;36(25):2603-2611. doi: 10.1200/JCO.2018.78.7192. Epub 2018 Jul 10.
citation: Boll B, Goergen H, Behringer K, Brockelmann PJ, Hitz F, Kerkhoff A, Greil R, von Tresckow B, Eichenauer DA, Burkle C, Borchmann S, Fuchs M, Diehl V, Engert A, Borchmann P. Bleomycin in older early-stage favorable Hodgkin lymphoma patients: analysis of the German Hodgkin Study Group (GHSG) HD10 and HD13 trials. Blood. 2016 May 5;127(18):2189-92. doi: 10.1182/blood-2015-11-681064. Epub 2016 Feb 1.
citation: Hay AE, Klimm B, Chen BE, Goergen H, Shepherd LE, Fuchs M, Gospodarowicz MK, Borchmann P, Connors JM, Markova J, Crump M, Lohri A, Winter JN, Dorken B, Pearcey RG, Diehl V, Horning SJ, Eich HT, Engert A, Meyer RM; Conducted by the NCIC Clinical Trials Group (Canada) and German Hodgkin Study Group (GHSG). An individual patient-data comparison of combined modality therapy and ABVD alone for patients with limited-stage Hodgkin lymphoma. Ann Oncol. 2013 Dec;24(12):3065-9. doi: 10.1093/annonc/mdt389. Epub 2013 Oct 11.
citation: Boll B, Gorgen H, Fuchs M, Pluetschow A, Eich HT, Bargetzi MJ, Weidmann E, Junghanss C, Greil R, Scherpe A, Schmalz O, Eichenauer DA, von Tresckow B, Rothe A, Diehl V, Engert A, Borchmann P. ABVD in older patients with early-stage Hodgkin lymphoma treated within the German Hodgkin Study Group HD10 and HD11 trials. J Clin Oncol. 2013 Apr 20;31(12):1522-9. doi: 10.1200/JCO.2012.45.4181. Epub 2013 Mar 18.