Phase III Study Comparing Irradiation at a Dose of 80 Gy to Irradiation at 70 Gy in Unfavorable Prostate Cancers Associated With Prolonged Hormonal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- UNICANCER
- 入组人数
- 500
- 试验地点
- 46
- 主要终点
- Biochemical or clinical progression-free survival at 5 years
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in treating patients with prostate cancer receiving hormone therapy.
详细描述
OBJECTIVES:
Primary
- Assess the impact of increasing the radiation dose 10 Gy on biochemical or clinical progression-free survival at 5 years in patients with unfavorable-risk prostate cancer receiving prolonged hormone therapy.
Secondary
- Evaluate overall and specific survival.
- Assess acute and late toxicities of different modalities (conformal or intensity-modulated radiotherapy).
- Evaluate toxicities of the different doses with respect to hormonal therapy.
- Assess the quality of life (QLQ-C30 and PR 25).
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Unfavorable disease, defined by at least 1 of the following criteria:
- •Clinical stage T3 or T4
- •Gleason score ≥8
- •Serum prostate-specific antigen (PSA) ≥20 ng/mL and ≤100 ng/mL
- •pN0 disease allowed if lymphadenectomy performed before patient began hormone therapy
- •No pelvic lymph nodes ≥15 mm by CT scan or MRI
- •No axillary lymph node involvement (pN1)
- •No bone metastasis
- •Must be starting hormonal treatment on or up to 6 months before beginning radiotherapy
- •PATIENT CHARACTERISTICS:
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Life expectancy >5 years
- •Must be enrolled in a social security program
- •No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years
- •No severe uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg)
- •No contraindication to luteinizing hormone-releasing hormone agonists
- •No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease)
- •No hip prosthesis
- •Must not be deprived of liberty or under guardianship
- •No geographical, social, or psychological reasons that would preclude follow up
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior pelvic irradiation
- •At least 3-4 months since prior transurethral resection
- •No other prior surgery for prostate cancer
- •No concurrent participation in another clinical trial which would require approval upon entry to this trial
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm I
Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
干预措施: intensity-modulated radiation therapy (Radiation)
Arm II
Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm II
Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
干预措施: intensity-modulated radiation therapy (Radiation)
结局指标
主要结局
Biochemical or clinical progression-free survival at 5 years
时间窗: 5 years
次要结局
- Acute and late toxicity(10 years)
- Quality of life as measured by QLQ-C30 and PR 25 questionnaires(10 years)
- Overall and specific survival(10 years)