HD11 for Intermediate Stages

Hodgkin´s Lymphoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264953
• Other study ID #: HD11
• Status: Completed
• Phase: Phase 3
• First received: December 12, 2005
• Last updated: August 3, 2011
• Start date: May 1998

Study information

• Verified date: July 2011
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1395
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin´s Lymphoma

Intervention

Drug:
• Adriamycin

• Bleomycin

• Vinblastine

• DTIC

• Etoposide

• Procarbazine

• Prednisone

• Vincristine

Radiation:
• radiation therapy
20 or 30Gy IF-RT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

References & Publications (1)

Eich HT, Diehl V, Görgen H, Pabst T, Markova J, Debus J, Ho A, Dörken B, Rank A, Grosu AL, Wiegel T, Karstens JH, Greil R, Willich N, Schmidberger H, Döhner H, Borchmann P, Müller-Hermelink HK, Müller RP, Engert A. Intensified chemotherapy and dose-reduce — View Citation

External Links

•   Description od study in German (Website of the Competence Network Malignant Lymphoma)