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

NCT ID: NCT00443677

Last Updated: 2009-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

307 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2007-06-30

Brief Summary

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

Detailed Description

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Conditions

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Advanced Hodgkin Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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abvd

Group Type ACTIVE_COMPARATOR

COPPEBVCAD vs BEACOPP vs ABVD

Intervention Type DRUG

beacopp

Group Type EXPERIMENTAL

COPPEBVCAD vs BEACOPP vs ABVD

Intervention Type DRUG

coppebvcad

Group Type EXPERIMENTAL

COPPEBVCAD vs BEACOPP vs ABVD

Intervention Type DRUG

Interventions

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COPPEBVCAD vs BEACOPP vs ABVD

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Studio Linfomi

OTHER

Sponsor Role lead

Responsible Party

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Gruppo Italiano Studio Linfomi

Principal Investigators

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Paolo Gobbi, MD

Role: PRINCIPAL_INVESTIGATOR

GISL

Emilio Iannitto, MD

Role: PRINCIPAL_INVESTIGATOR

GISL

Giuseppe Polimeno, MD

Role: PRINCIPAL_INVESTIGATOR

GISL

Locations

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Centro Oncologico Modenese

Modena, , Italy

Site Status

Countries

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Italy

Other Identifiers

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HD2000

Identifier Type: -

Identifier Source: org_study_id

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