A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 602
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: A PET scan may help doctors learn how the cancer responded to combination chemotherapy and whether radiation therapy is also required.
PURPOSE: This randomized phase III trial is studying giving a PET scan to see how well it works in deciding whether patients who have received combination chemotherapy for stage IA or stage IIA Hodgkin lymphoma also need radiation therapy.
详细描述
OBJECTIVES:
- Determine whether patients with stage IA or IIA Hodgkin lymphoma who have a negative fludeoxyglucose F 18 positron emission tomography (FDG-PET) imaging after 3 courses of chemotherapy comprising doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine (ABVD) require consolidation radiotherapy (to areas of previous involvement) in order to delay or prevent disease progression.
OUTLINE: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV, and dacarbazine IV (ABVD) on days 1 and 15. Treatment repeats every 28 days for 3 courses. On day 15 of the third course of chemotherapy, patients undergo a CT scan of the neck, thorax, abdomen and pelvis. Patients with nonresponsive disease or progressive disease are removed from the study. Patients who achieve response undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET). Patients with a positive FDG-PET scan receive an additional course of ABVD and undergo involved field radiotherapy. Patients with a negative FDG-PET scan are randomized to 1 of 2 treatment arms.
- Arm I: Within 6 weeks after completion of course 3 of chemotherapy, patients undergo involved field radiotherapy to disease areas.
- Arm II: Patients receive no further treatment. After completion of study therapy, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed Hodgkin Lymphoma
- •Stage IA or IIA disease
- •No stage IA Hodgkin lymphoma with no clinical or CT evidence of disease after diagnostic biopsy
- •Above the diaphragm with no mediastinal bulk, defined as maximum transverse diameter of mediastinal mass
- •Internal thoracic diameter at level of D5/6 interspace > 0.33
- •Bulky disease at other sites, defined as nodal mass with transverse diameter ≥ 10 cm allowed
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for ≥ 6 months
- •No prior malignancy except appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •No severe underlying illness considered to make the trial therapy hazardous (i.e., severe heart disease or lung fibrosis)
- •Willing to travel to the nearest PET scan center
- •Able to comply with protocol follow-up arrangements
- •PRIOR CONCURRENT THERAPY:
- •No prior treatment for Hodgkin lymphoma
- •No contraindications to chemotherapy or radiotherapy
排除标准
- 未提供
研究组 & 干预措施
Arm I
Within 6 weeks after completion of course 3 of chemotherapy, patients undergo involved field radiotherapy to disease areas.
干预措施: Involved Field Radiotherapy (Radiation)
Arm II
Patients receive no further treatment.
干预措施: No further treatment (Other)
结局指标
主要结局
Progression-free survival
时间窗: up to 5 years after randomisation
次要结局
- Incidence and type of second cancers(up to 5 years after randomisation)
- Survival and cause of death(up to 5 years after randomisation)
- Incidence of FDG-PET scan positivity/negativity after 3 courses of chemotherapy(3 months after treatment start)