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

September 10, 2005
December 28, 2005
May 2000
Not Provided
  • - 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
Same as current
Complete list of historical versions of study NCT00188149 on ClinicalTrials.gov Archive Site
  • - Evaluation of the quality of life of the patients during and after the therapy
  • - Occurence of late toxicity after the end of the therapy
Same as current
Not Provided
Not Provided
 
Optimization of the Primary Therapy for Patients With Hodgkin's Disease and Evaluation of PET
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

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hodgkin Disease
  • Drug: Combined chemotherapy (ABVD, BACOPP-D)
  • Procedure: Radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2007
Not Provided

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
Both
16 Years to 75 Years
No
Contact: Ralph Naumann, MD 458-3855 ext +49 351 Ralph.Naumann@uniklinikum-dresden.de
Germany
 
NCT00188149
CGC05MK1002
Not Provided
Not Provided
University Hospital Carl Gustav Carus
Technische Universität Dresden
Principal Investigator: Ralph Naumann, MD University Clinic "Carl Gustav Carus" Dresden
University Hospital Carl Gustav Carus
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP