Clinical trial NCT00736320: HD16 for Early Stage Hodgkin Lymphoma
Official title: HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hodgkin Lymphoma
Keywords: Hodgkin Lymphoma
early stage
PET
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2008-08-15
Enrollment: 1150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS).


Eligibility criteria: Inclusion Criteria:

* Hodgkin Lymphoma
* CS I, II without risk factors

  * large mediastinal mass (\> 1/3 of maximum transverse thorax diameter)
  * extranodal involvement
  * elevated ESR
  * 3 or more involved nodal areas
* Written informed consent

Exclusion Criteria:

* Leucocytes \< 3000/µl
* Platelets \< 100000/µl
* Hodgkin Lymphoma as composite lymphoma
* Activity index (WHO) \> 2

Primary outcomes:
measure: Progression Free Survival
timeFrame: 5 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: acute toxicity
timeFrame: 5 years
measure: late toxicity
timeFrame: 5 years
measure: CR rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: 1st Dept. of Medicine, Cologne University Hospital
Study officials:
affiliation: University of Cologne
name: Andreas Engert, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Heek L, Stuka C, Kaul H, Muller H, Mettler J, Hitz F, Baues C, Fuchs M, Borchmann P, Engert A, Dietlein M, Voltin CA, Kobe C. Predictive value of baseline metabolic tumor volume in early-stage favorable Hodgkin Lymphoma - Data from the prospective, multicenter phase III HD16 trial. BMC Cancer. 2022 Jun 18;22(1):672. doi: 10.1186/s12885-022-09758-z.
citation: Fuchs M, Goergen H, Kobe C, Kuhnert G, Lohri A, Greil R, Sasse S, Topp MS, Schafer E, Hertenstein B, Soekler M, Vogelhuber M, Zijlstra JM, Keller UB, Krause SW, Wilhelm M, Maschmeyer G, Thiemer J, Duhrsen U, Meissner J, Viardot A, Eich H, Baues C, Diehl V, Rosenwald A, von Tresckow B, Dietlein M, Borchmann P, Engert A. Positron Emission Tomography-Guided Treatment in Early-Stage Favorable Hodgkin Lymphoma: Final Results of the International, Randomized Phase III HD16 Trial by the German Hodgkin Study Group. J Clin Oncol. 2019 Nov 1;37(31):2835-2845. doi: 10.1200/JCO.19.00964. Epub 2019 Sep 10.
citation: Voltin CA, Goergen H, Baues C, Fuchs M, Mettler J, Kreissl S, Oertl J, Klaeser B, Moccia A, Drzezga A, Engert A, Borchmann P, Dietlein M, Kobe C. Value of bone marrow biopsy in Hodgkin lymphoma patients staged by FDG PET: results from the German Hodgkin Study Group trials HD16, HD17, and HD18. Ann Oncol. 2018 Sep 1;29(9):1926-1931. doi: 10.1093/annonc/mdy250.
citation: Narang AK, Terezakis SA. Contemporary radiation therapy in combined modality therapy for Hodgkin lymphoma. J Natl Compr Canc Netw. 2015 May;13(5):597-605. doi: 10.6004/jnccn.2015.0077.