NCT00736320

Trial name or title	HD16 for Early Stages ‐ Treatment optimisation trial in the first‐line treatment of early stage Hodgkin lymphoma; treatment stratification by means of FDG‐PET
Starting date	November 2009
Contact information	Prof. Dr. Andreas Engert, University of Cologne, Germany
Notes	Study design Randomised clinical trial (phase III) including 1150 participants with HL Country/treatment centre 1st Department of Medicine, Cologne University Hospital, Cologne, Germany Number of included participants Total: 1150 Inclusion criteria Hodgkin lymphoma Adults (18 to 75 years) CS I and II without risk factors (large mediastinal mass (> 1/3 of maximum transverse thorax diameter), extranodal involvement, elevated ESR, three or more involved nodal areas) Written informed consent Exclusion criteria Leukocytes < 3000/µl Platelets < 100000/µl Hodgkin lymphoma as composite lymphoma Activity index (WHO) > 2 Arms and interventions Active comparator (A): two cycles ABVD followed by 20 Gy IF‐RT, irrespective of FDG‐PET results after chemotherapy Expertimental (B): two cycles ABVD followed by 20 Gy IF‐RT if FDG‐PET is positive after chemotherapy; 2 cycles ABVD and treatment stop if FDG‐PET is negative after chemotherapy Primary outcome measure(s) Progression‐free survival Time frame: five years Secondary outcome measure(s) Overall survival Acute toxicity Late toxicity Complete response rate Time frame: five years Estimated study completion date May 2020

ESR: erythrocyte sedimentation rate; FDG: [18F]‐fluorodeoxy‐D‐glucose; HL: Hodgkin lymphoma; IF‐RT :involved‐field radiation therapy; MDCT: multi detector computed tomography; WHO: World Health Organization