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NCT00736320 Clinical Trial

HD16 for Early Stage Hodgkin Lymphoma

Hodgkin Lymphoma Clinical Trial

— HD16  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00736320
Other study ID # HD16
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 2009
Est. completion date December 2021

Study information
Verified date November 2020
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1150
Est. completion date December 2021
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
chemotherapy with 2 cycles of ABVD (day 1 + 15)
Radiation:
• 20 Gy IFRT (Involved Field Radiotherapy)
20 Gy Involved Field Radiotherapy

Locations
Country Name City State
Germany 1st Dept. of Medicine, Cologne University Hospital Cologne

Sponsors (1)
Lead Sponsor Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression Free Survival 5 years
Secondary overall survival 5 years
Secondary acute toxicity 5 years
Secondary late toxicity 5 years
Secondary CR rate 5 years
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