HD10 for Early Stages - Full Text View

Sponsored by:	University of Cologne
Information provided by:	University of Cologne
ClinicalTrials.gov Identifier:	NCT00265018

Purpose

This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.

Condition	Intervention	Phase
Hodgkin´s Lymphoma	Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Procedure: radiation therapy	Phase III

MedlinePlus related topics: Hodgkin's Disease Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Vinblastine Vinblastine sulfate Bleomycin Bleomycin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Factorial Assignment, Efficacy Study

Further study details as provided by University of Cologne:

Study Start Date:

May 1998

Eligibility

Ages Eligible for Study:	16 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hodgkin´s lymphoma (histologically proven)
CS (PS) IA, IB, IIA,IIB without any of the following risk factors:
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265018

Sponsors and Collaborators

University of Cologne

Investigators

Principal Investigator:

Volker Diehl, Prof.

University of Cologne

More Information

Description of study in Gereman (Website of the Competence Network Malignant Lymphoma This link exits the ClinicalTrials.gov site

Study ID Numbers:	HD10
Study First Received:	December 12, 2005
Last Updated:	August 7, 2007
ClinicalTrials.gov Identifier:	NCT00265018
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:

Hodgkin´s lymphoma
early stages

Study placed in the following topic categories:

Lymphatic Diseases
Hodgkin's disease
Immunoproliferative Disorders
Hodgkin lymphoma, adult
Vinblastine

Lymphoproliferative Disorders
Bleomycin
Hodgkin Disease
Lymphoma
Doxorubicin

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009