HD10 for Early Stages

University of Cologne

Status and phase: Completed; Phase 3

Conditions: Hodgkin´s Lymphoma

Treatments: Drug: Adriamycin; Drug: DTIC; Drug: Vinblastine; Drug: Bleomycin; Radiation: 20 Gy IF-RT; Radiation: 30 Gy IF-RT

Study type: Interventional

Funder types: Other

Identifiers

NCT00265018

HD10

Details and patient eligibility

About

This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.

Enrollment: 1,370 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hodgkin´s lymphoma (histologically proven)

• CS (PS) IA, IB, IIA,IIB without any of the following risk factors:

  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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,370 participants in 4 patient groups

Arm A

Active Comparator group

Treatment:

Drug: Adriamycin

Drug: DTIC

Drug: Vinblastine

Drug: Bleomycin

Radiation: 30 Gy IF-RT

Arm B

Experimental group

Treatment:

Drug: Adriamycin

Drug: DTIC

Drug: Vinblastine

Radiation: 20 Gy IF-RT

Drug: Bleomycin

Arm C

Experimental group

Treatment:

Drug: Adriamycin

Drug: DTIC

Drug: Vinblastine

Drug: Bleomycin

Radiation: 30 Gy IF-RT

Arm D

Experimental group

Treatment:

Drug: Adriamycin

Drug: DTIC

Drug: Vinblastine

Radiation: 20 Gy IF-RT

Drug: Bleomycin