HD16 for Early Stage Hodgkin Lymphoma

University of Cologne1,150 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,150

Conditions

Hodgkin Lymphoma

Interventions

ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)DRUG

chemotherapy with 2 cycles of ABVD (day 1 + 15)

20 Gy IFRT (Involved Field Radiotherapy)RADIATION

20 Gy Involved Field Radiotherapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

1st Dept. of Medicine, Cologne University Hospital

Cologne, Germany

Outcomes

Primary Outcomes

Progression Free Survival

Time frame: 5 years

Secondary Outcomes

overall survival

Time frame: 5 years

acute toxicity

Time frame: 5 years

late toxicity

Time frame: 5 years

CR rate

Time frame: 5 years

Data from ClinicalTrials.gov

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