Treatment of Advanced Hodgkin's Disease (Stages IIB-III-IV)

Phase 3

Completed

• Conditions: Advanced Hodgkin Disease
• Interventions: Drug: COPPEBVCAD vs BEACOPP vs ABVD

• Registration Number: NCT00443677
• Lead Sponsor: Gruppo Italiano Studio Linfomi

Brief Summary

The purpose of this study is to compare the toxicities of the COPPEBVCAD vs BEACOPP vs ABVD regimens.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2007-03-05
• Study First Submitted QC: 2007-03-05
• Study First Posted: 2007-03-06
• Study Completion: 2007-06
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-19
• Last Update Posted: 2009-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

Inclusion Criteria

• Histologically confirmed diagnosis of Hodgkin disease
• Clinical stage IIB, III, IV
• No prior treatment for Hodgkin disease or other malignancy
• Age 18-65 year
• Good cardiac, pulmunar, renal and hepatic function
• Performance status 0-3 (Karnofsky 100- 40)
• Written Informed Consent

Exclusion Criteria

• HIV positivity
• Large cell, anaplastic, CD30+ lymphoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
abvd	COPPEBVCAD vs BEACOPP vs ABVD	-
beacopp	COPPEBVCAD vs BEACOPP vs ABVD	-
coppebvcad	COPPEBVCAD vs BEACOPP vs ABVD	-

Primary Outcome Measures

Name	Time	Method
To compare the toxicity of the COPPEBVCAD vs BEACOPP vs ABVD regimens

Secondary Outcome Measures

Name	Time	Method
To compare the results in terms of response, failure free survival and relapse free survival of the three regimens

Trial Locations

Locations (1)

Centro Oncologico Modenese; 🇮🇹 Modena, Italy