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
16 Years
75 Years
Both
Hodgkin Disease
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
- Feasibility and acute toxicity of the therapy
Principal Investigator
Ralph Naumann, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Clinic "Carl Gustav Carus" Dresden
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
CGC05MK1002
NCT ID:
NCT00188149
Start Date:
May 2000
Completion Date:
December 2007
Related Keywords:
- Hodgkin Disease
- Hodgkin's Lymphoma
- Chemotherapy
- Radiation therapy
- PET
- Hodgkin Disease
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