HD11 for Intermediate Stages

Sponsor

University of Cologne (Other)

Overall Status

Completed

CT.gov ID

NCT00264953

Collaborator

(none)

1,395

Enrollment

Arms

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin´s Lymphoma	Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Drug: Etoposide Drug: Procarbazine Drug: Prednisone Drug: Vincristine Radiation: radiation therapy	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1395 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

May 1, 1998

Actual Primary Completion Date :

Jan 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A 4x ABVD plus 30Gy IF-RT	Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Radiation: radiation therapy 20 or 30Gy IF-RT
Experimental: C 4x BEACOPP baseline plus 30Gy IF-RT	Drug: Adriamycin Drug: Bleomycin Drug: Etoposide Drug: Procarbazine Drug: Prednisone Drug: Vincristine Radiation: radiation therapy 20 or 30Gy IF-RT
Experimental: B 4x ABVD plus 20Gy IF-RT	Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Radiation: radiation therapy 20 or 30Gy IF-RT
Experimental: D 4x BEACOPP baseline plus 20Gy IF-RT	Drug: Adriamycin Drug: Bleomycin Drug: Etoposide Drug: Procarbazine Drug: Prednisone Drug: Vincristine Radiation: radiation therapy 20 or 30Gy IF-RT