Status:
UNKNOWN
Optimization of the Primary Therapy for Patients With Hodgkin's Disease and Evaluation of PET
Lead Sponsor:
University Hospital Carl Gustav Carus
Collaborating Sponsors:
Technische Universität Dresden
Conditions:
Hodgkin Disease
Eligibility:
All Genders
16-75 years
Phase:
PHASE4
Brief Summary
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 sec...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (HL1):
- Histologically confirmed Hodgkin´s Lymphoma (WHO Classification 1999)
- Classical Hodgkin Lymphoma: Nodular sclerosis (type 1 and 2) / Mixed type / Lymphocyte depleted type / Lymphocyte rich type
- 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)
- Classical Hodgkin´s Lymphoma: Nodular sclerosis (type 1 and 2) / Mixed type / Lymphocyte depleted type / Lymphocyte rich type
- Nodular lymphocyte-predominant Hodgkin Lymphoma
- Patients in stage
- 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
- 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)
- Classical Hodgkin's Lymphoma (Hodgkin's desease): Nodular sclerosis (type 1 and 2) / Mixed type / Lymphocyte depleted type / Lymphocyte rich type
- Nodular lymphocyte-predominant Hodgkin Lymphoma
- Patients in stage
- 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
- Clinical stage (CS) III
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00188149
Start Date
May 1 2000
End Date
December 1 2007
Last Update
December 29 2005
Active Locations (1)
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1
Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus
Dresden, Saxony, Germany, 01307