Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,216
- 试验地点
- 52
- 主要终点
- Time to biochemical or clinical failure
研究概览
简要总结
RATIONALE: 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 schedule of intensity-modulated radiation therapy is more effective in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying the side effects of three schedules of intensity-modulated radiation therapy and compares how well they work in treating patients with localized prostate cancer.
详细描述
OBJECTIVES:
- Determine the safety and efficacy of conventional vs hypofractionated high-dose intensity-modulated radiotherapy in patients with localized prostate cancer.
- Determine the side effects of these regimens in these patients.
- Determine whether hypofractionated radiotherapy schedules will improve the therapeutic ratio by either improving tumor control or reducing normal tissue side effects.
- Compare acute and late treatment-related gastrointestinal and urological toxicity in these patients.
- Determine different prostate-specific antigen-related endpoints for local failure and distant metastases.
- Extend the database of patients treated to escalated doses with dose-volume histograms (DVHs) of normal tissues at risk and relate these to common toxicity endpoints.
- Develop a model to estimate normal tissue complication probability (NTCP) of rectum and bladder for hypofractionated as well as conventional dose-escalated radiotherapy schedules.
OUTLINE: This is a multicenter, randomized, pilot study. Patients are stratified according to risk of seminal vesicle involvement (low-risk vs moderate-risk or high-risk).
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Hormone therapy: Patients receive androgen-deprivation therapy comprising an injection of luteinizing hormone-releasing hormone (LHRH) agonist once monthly for 3-6 months and oral cyproterone acetate beginning the week before the first LHRH agonist injection and continuing for at least 2 weeks after each LHRH agonist injection. Within one week after the last LHRH agonist injection, patients proceed to radiotherapy.
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Radiotherapy: Patients are randomized to 1 of 3 treatment arms.
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Arm I: Patients undergo conventional high-dose intensity-modulated radiotherapy (IMRT) in 37 fractions over 7.5 weeks.
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Arm II: Patients undergo hypofractionated high-dose IMRT in 20 fractions over 4 weeks.
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Arm III: Patients undergo hypofractionated high-dose IMRT in 19 fractions over 3.8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 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, meeting the following criteria:
- •Clinical stage T1b-T3a, N0, M0
- •Locally confined disease
- •Previously untreated disease
- •Prostate-specific antigen (PSA) ≤ 30 ng/mL
- •Estimated risk of seminal vesicle involvement < 30%
- •Estimated risk of seminal vesicle involvement is defined as PSA + ([Gleason score - 6] x 10) (i.e., if Gleason score ≤ 6, then PSA must be ≤ 30 ng/mL; if Gleason score = 7, then PSA must be < 20 ng/mL; if Gleason score = 8, then PSA must be < 10 ng/mL; if Gleason score = 9 or 10 patient is ineligible)
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0 or 1
- •Life expectancy > 10 years (5 years for patients with poorly differentiated cancers)
- •WBC > 4,000/mm^3
- •Hemoglobin > 11g/dL
- •Platelet count > 100,000/mm^3
- •No other active malignancy within the past 5 years except basal cell carcinoma
- •No hip prosthesis or fixation that would interfere with standard radiation beam configuration
- •No comorbid conditions likely to impact on the advisability of radical radiotherapy (e.g., previous inflammatory bowel disease, previous colorectal surgery, significant bladder instability, or urinary incontinence)
- •PRIOR CONCURRENT THERAPY:
- •No prior pelvic radiotherapy
- •No prior radical prostatectomy
- •No prior androgen-deprivation therapy
- •No concurrent full anticoagulation therapy with warfarin or heparin
排除标准
- 未提供
结局指标
主要结局
Time to biochemical or clinical failure
时间窗: Defined as the time from randomisation to biochemical failure or prostate cancer recurrence up to 5 years
Phoenix consensus guidelines as a PSA concentration greater than nadir plus 2 ng/mL.
次要结局
- Acute and late side-effects(Peak and week 18 bowel and bladder side-effects)
- Overall survival(Time from randomisation to death from any cause up to 15 years)
- Development of metastases(Time from randomisation to development of metastases up to 15 years)
- Disease-free survival(time from randomisation to any prostate cancer-related event or death from any cause up to 15 years)
- Recommencement of hormonal treatment for disease recurrence(Time from randomisation to recommencement of hormone treatment for disease recurrence up to 15 years)