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
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- - Feasibility and acute toxicity of the therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •(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
结局指标
主要结局
- 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
次要结局
- - Evaluation of the quality of life of the patients during and after the therapy
- - Occurence of late toxicity after the end of the therapy