Optimization of the Primary Therapy for Patients With Hodgkin's Disease and Evaluation of PET

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Hospital Carl Gustav Carus.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Technische Universität Dresden
Information provided by:
University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier:
NCT00188149
First received: September 10, 2005
Last updated: December 28, 2005
Last verified: September 2005
  Purpose

Prognosis of patients with Hodgkin´s lymphoma (HL) has been improved significantly over the last decade. Therefore, the impact of treatment associated long-term toxicities and late effects such as second cancers increased. The purpose of this prospective multicenter trial is to show the feasibility of the treatment with ABVD alone in patients with limited stage (HL1) and intermediate stage (HL2) disease and of an intensified etoposide-free chemotherapy regimen for patients with advanced disease (HL3) including 18F-FDG-PET evaluation.


Condition Intervention Phase
Hodgkin Disease
Drug: Combined chemotherapy (ABVD, BACOPP-D)
Procedure: Radiation therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimization of the Primary Therapy for Patients With Hodgkin's Lymphoma and Evaluation of the Positron Emission Tomography (PET) as a Diagnostic Tool for Primary Staging and Assessment of the Effects of the Therapy

Resource links provided by NLM:


Further study details as provided by University Hospital Carl Gustav Carus:

Primary Outcome Measures:
  • - Feasibility and acute toxicity of the therapy
  • - The Free from Therapy Failure (FFTF) rate after one year
  • - Event-Free Survival (EFS) rate and overall survival rate
  • - Evaluation of the PET as a diagnostic tool for the primary tumor staging as well for assessment of the effects of the therapy

Secondary Outcome Measures:
  • - Evaluation of the quality of life of the patients during and after the therapy
  • - Occurence of late toxicity after the end of the therapy

Estimated Enrollment: 300
Study Start Date: May 2000
Estimated Study Completion Date: December 2007
Detailed Description:

The aim in limited and intermediate stages is to reduce the toxicity by omitting the subsequent radiotherapy in patients with complete remission after ABVD chemotherapy. Patients with limited disease receive four cycles, patients with intermediate disease (according to the criteria of the German Hodgkin Study group, GHSG) receice six cycles of ABVD. In case of residual mass (> 1.5 cm), additional involved field irradiation is planned. The aim in advanced disease using BACOPP-D regimen which includes cyclophosphamide, adriamycin, dacarbazine, procarbazine, prednisolone, bleomycin and vincristine, is to reduce the hematological toxicity and the secondary leukemias by omitting etoposide (in comparison to the BEACOPP escalated regimen). All patients receive eight cycles of the BACOPP-D regimen. In case of residual mass (> 1.5 cm), additional involved field irradiation is planned. Additionally, we want to evaluate the CT- and PET-based remission status after chemotherapy and at final staging.

  Eligibility

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

Inclusion Criteria (HL1):

  • Histologically confirmed Hodgkin´s Lymphoma (WHO Classification 1999)

    1. Classical Hodgkin Lymphoma: Nodular sclerosis (type 1 and 2) / Mixed type / Lymphocyte depleted type / Lymphocyte rich type
    2. Nodular lymphocyte-predominant Hodgkin Lymphoma
  • Patients in stage: Clinical stage (CS) I without risk factors / CS II without risk factors
  • Age between 16 and 75
  • Written informed consent

Inclusion criteria (HL2):

  • Histologically confirmed Hodgkin´s Lymphoma (WHO Classification 1999)

    1. Classical Hodgkin´s Lymphoma: Nodular sclerosis (type 1 and 2) / Mixed type / Lymphocyte depleted type / Lymphocyte rich type
    2. Nodular lymphocyte-predominant Hodgkin Lymphoma
  • Patients in stage

    1. Clinical stage (CS) I,II A with risk factors: Large mediastinal tumor (>1/3 of the maximal diameter of the thoracic cavity) / Extranodal disease / Sedimentation rate ≥ 50 mm/h for patients without B-symptomes or ≥ 30 mm/h for patients with B-symptomes / ≥ 3 lymph node areas infiltrated with tumor cells
    2. Clinical stage (CS) II B with risk factors: Sedimentation rate ≥ 50 mm/h for patients without B-symptomes or ≥ 30 mm/h for patients with B-symptomes / ≥ 3 lymph node areas infiltrated with tumor cells
  • Age between 16 and 75
  • Written informed consent

Inclusion criteria (HL3):

  • Histologically confirmed Hodgkin´s Lymphoma (WHO Classification 1999)

    1. Classical Hodgkin's Lymphoma (Hodgkin's desease): Nodular sclerosis (type 1 and 2) / Mixed type / Lymphocyte depleted type / Lymphocyte rich type
    2. Nodular lymphocyte-predominant Hodgkin Lymphoma
  • Patients in stage

    1. Clinical stage (CS) II B with minimum one of the following risk factors: Large mediastinal tumor (≥1/3 of the maximal diameter of the thoracic cavity) / Extranodal disease
    2. Clinical stage (CS) III
    3. Clinical stage (CS) IV
  • Age between 16 and 65
  • Written informed consent

Exclusion Criteria (HL1, HL2 and HL3):

  • Poor general condition not related to the lymphoma (ECOG perfomance status 3 or 4; Karnofsky Index < 50 %)
  • Severe concomitant diseases: cardiac insufficiency (NYHA grade III or IV) / chronic respiratory insufficiency with hypoxemia / Hepatic insufficiency (cirrhosis, Hepatitis B or C / chronic renal insufficiency / HIV infection or other out-of-control infections / hematopoetic insufficiency (Leukocytes < 3000/µl; Thrombocytes < 100.000/µl / psychiatric diseases
  • History of previous malignancy in the last 5 years
  • Pregnancy
  • Patients not likely to comply to the requirements stemming form the participation in the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188149

Contacts
Contact: Ralph Naumann, MD 458-3855 ext +49 351 Ralph.Naumann@uniklinikum-dresden.de

Locations
Germany
Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus Recruiting
Dresden, Sachsen, Germany, 01307
Contact: Ralph Naumann, MD         
Sponsors and Collaborators
University Hospital Carl Gustav Carus
Technische Universität Dresden
Investigators
Principal Investigator: Ralph Naumann, MD University Clinic "Carl Gustav Carus" Dresden
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00188149     History of Changes
Other Study ID Numbers: CGC05MK1002
Study First Received: September 10, 2005
Last Updated: December 28, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Carl Gustav Carus:
Hodgkin's Lymphoma
Chemotherapy
Radiation therapy
PET

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014