Open Label, Randomized Phase III Trial of Hormone Therapy Alone Versus COmbined HOrmone With Radiation Therapy in Clinical Pelvic Lymph Node Metastatic Prostate Cancer (COHORT Trial)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Comparison of recurrence-free survival between two treatment groups
研究概览
简要总结
In local advanced prostate cancer patients with clinically positive metastatic regional lymph node, the optimal treatment is still unanswered. For these patients, radiotherapy combined with hormonal therapy or hormonal therapy alone are recommended. Recently, the reports from NCCB and SEER data showed that radiotherapy combined with hormonal therapy have better survivals than hormonal therapy alone.
This randomized phase III trial compare hormonal therapy alone with combined hormone with radiotherapy in clinically pelvic lymph node metastatic prostate cancer.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •pathologically confirmed prostate cancer within 6 months for study enrollment
- •Clincally enlarged pelvic lymph node ((short axis 0.5 cm ≤) in imaging studies (CT, MRI, PET-CT) at diagnosis and partial response or complete remission of enlarged lymph nodes according to RECIST v1.1 after hormonal therapy for 2-3 months
- •ECOG performance status 0-1
- •Optimal hematologic profiles within 6 months for study enrollment
- •Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
- •Platelets ≥ 50,000 cells/mm3
- •Hemoglobin ≥ 8.0 g/dl
- •Optimal kidney function within 6 months for study enrollment
- •Creatinine < 2.0 ng/dL
- •Optimal liver functions within 6 months for study enrollment
- •total bilirubin < 1.5 X maximum normal value
- •alanine aminotransferase or aspartate aminotransferase < 2.5 X maximum normal value
排除标准
- •combined with distant metastasis (retroperitoneal lymph node, bone,...)
- •previous history of antiandrogen therapy within 6 months of study enrollment
- •previous history of definitive prostate cancer treatment such as prostatectomy
- •previous history of pelvic radiotherapy
- •previous history of other cancer treatment except for skin cancer and theroid cancer
结局指标
主要结局
Comparison of recurrence-free survival between two treatment groups
时间窗: 5-year
expected 5-year recurrence-free survival were 40% in hormonal therapy alone group and more than 80% in hormonal therapy combined with radiotherapy
次要结局
- Comparison of quality of lifl between two treatment groups(5-year)
- Comparison of toxicities between two treatment groups(5-year)
- Comparison of overall survival between two treatment groups(5-year)
- Comparison of cause-specific survival between two treatment groups(5-year)
- Comparison of clinical failure free survival between two treatment groups(5-year)