Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 95
- 主要终点
- Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD
研究概览
简要总结
This phase II trial studies how well chemotherapy based on positron emission tomography (PET) scan works in treating patients with stage I or stage II Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells and allow doctors to save the part of the body where the cancer started. Comparing results of diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
详细描述
PRIMARY OBJECTIVES:
I. To determine the progression-free survival (PFS) from enrollment for patients with non-bulky stage I and II Hodgkin lymphoma.
II. To compare the PFS of patients who are PET positive versus PET negative following 2 cycles of doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD).
SECONDARY OBJECTIVES:
I. To evaluate the complete response (CR) rate of patients diagnosed with non-bulky stage I and II Hodgkin lymphoma following PET response-adapted chemotherapy with or without radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment (chemotherapy and F-18 PET/CT)
See Detailed Description
干预措施: Bleomycin Sulfate (Biological)
Treatment (chemotherapy and F-18 PET/CT)
See Detailed Description
干预措施: Doxorubicin Hydrochloride (Drug)
Treatment (chemotherapy and F-18 PET/CT)
See Detailed Description
干预措施: Procarbazine Hydrochloride (Drug)
Treatment (chemotherapy and F-18 PET/CT)
See Detailed Description
干预措施: Vinblastine Sulfate (Drug)
Treatment (chemotherapy and F-18 PET/CT)
See Detailed Description
干预措施: Dacarbazine (Drug)
Treatment (chemotherapy and F-18 PET/CT)
See Detailed Description
干预措施: Cyclophosphamide (Drug)
Treatment (chemotherapy and F-18 PET/CT)
See Detailed Description
干预措施: computed tomography (Procedure)
Treatment (chemotherapy and F-18 PET/CT)
See Detailed Description
干预措施: Etoposide phosphate (Drug)
Treatment (chemotherapy and F-18 PET/CT)
See Detailed Description
干预措施: prednisone (Drug)
Treatment (chemotherapy and F-18 PET/CT)
See Detailed Description
干预措施: Radiation Therapy (Drug)
Treatment (chemotherapy and F-18 PET/CT)
See Detailed Description
干预措施: Fludeoxyglucose F-18 (Radiation)
Treatment (chemotherapy and F-18 PET/CT)
See Detailed Description
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD
时间窗: 36 Months
The primary objective of this trial is to estimate the 3 year PFS in patients who received 4 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, all patients that received 4 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) are included.
36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation.
时间窗: at 36 months
All patients received an initial 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15. After the first 2 cycles of ABVD, PET/CT was performed and submitted for central review (cycle 2, days 23-25) and determined whether patients would receive 2 cycles of escalated BEACOPP and involved-field RT (IFRT) or an additional 2 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS rate at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, we compare the PFS rate between patients who received 4 cycles of ABVD and patients who received 2 cycles of ABVD and 2 cycles of IFRT.
次要结局
- Complete Response Rate(Up to 5 years)
