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

U

University Hospital Carl Gustav Carus

Status and phase

Unknown
Phase 4

Conditions

Hodgkin Disease

Treatments

Procedure: Radiation therapy
Drug: Combined chemotherapy (ABVD, BACOPP-D)

Study type

Interventional

Funder types

Other

Identifiers

NCT00188149
CGC05MK1002

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

16 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Central trial contact

Ralph Naumann, MD

Data sourced from clinicaltrials.gov

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