HD11 for Intermediate Stages

University of Cologne1,395 enrolled

Overview

This study is designed to (1) compare the efficacy of the BEACOPP regimen with that of ABVD as a 4-cycle chemotherapy combined with an involved field irradiation and (2) to define the optimum radiation dose comparing of 30 to 20 Gy in the same context.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,395

Conditions

Hodgkin´s Lymphoma

Interventions

AdriamycinDRUG

BleomycinDRUG

VinblastineDRUG

DTICDRUG

Eligibility

Sex: ALLMin age: 16 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hodgkin´s lymphoma (histologically proven) * CS (PS) IA, IB, IIA, with one of the risk factors a-d CS (PS) IIB only with risk factor c or d 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

Data from ClinicalTrials.gov

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