HD12 for Advanced Stages

• Sponsor: University of Cologne (Other)
• Overall Status: Completed
• CT.gov ID: NCT00265031
• Collaborator: (none)

Study Details

Study Description

Brief Summary

This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin´s Lymphoma	Drug: Cyclophosphamide; Drug: Adriamycin; Drug: Etoposide; Drug: Procarbazine; Drug: Prednisone; Drug: Vincristine; Drug: Bleomycin; Procedure: radiation therapy	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Hodgkin´s lymphoma (histologically proven)

• CS(PS) IIB with one or both of the risk factors:

1. bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)

2. extranodal involvement

• CS(PS) III, IV

• written informaed consent

Exclusion Criteria:

• Leukocytes <3000/microl

• Platelets <100000/microl

• Hodgkin´s Disease as "composite lymphoma"

• Activity index (WHO) < grade 2

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Cologne

Investigators

• Principal Investigator: Volker Diehl, Prof., University of Cologne

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00265031
• Other Study ID Numbers: HD12
• First Posted: Dec 13, 2005
• Last Update Posted: Jun 25, 2012
• Last Verified: Aug 1, 2007

• Keywords provided by , ,: Hodgkin´s Lymphoma; advanced stages
• Additional relevant MeSH terms: Hodgkin Disease; Prednisone; Cyclophosphamide; Etoposide; Vincristine; Doxorubicin; Liposomal doxorubicin; Bleomycin; Procarbazine

Study Results

No Results Posted as of Jun 25, 2012