NCT00331773已完成3 期
A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,116
- 试验地点
- 296
- 主要终点
- Five-year Disease-free Survival (DFS) Rate
研究概览
简要总结
RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving hypofractionated radiation therapy (higher doses over a shorter period of time), may be less costly with fewer side effects and just as effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying several different radiation therapy regimens to compare how well they work in treating patients with stage II prostate cancer.
详细描述
OBJECTIVES:
Primary
- Compare the disease-free survival (DFS) of patients with favorable-risk stage II prostate cancer treated with hypofractionated vs conventionally fractionated three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT).
Secondary
- Compare time to local progression, freedom from biochemical recurrence, and disease-specific and overall survival of patients treated with these regimens.
- Determine the incidence of gastrointestinal and genitourinary toxic effects in patients treated with these regimens.
- Compare the degree, duration, and significant differences in disease-specific health-related quality of life (HRQOL) decrements, using the Expanded Prostate Cancer Index Composite (EPIC), in patients treated with these regimens.
- Determine whether anxiety and/or depression, as measured by the Hopkins Symptom Checklist-25 (HSCL-25), are decreased with therapy that improves DFS of these patients .
- Determine whether the incremental gain in DFS outweighs decrements in the generic domains of HRQOL (i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression) in patients treated with these regimens.
- Conduct a cost-utility analysis of hypofractionated 3D-CRT or IMRT as a prostate cancer therapy if this regimen is shown to be as effective as conventionally fractionated 3D-CRT or IMRT in improving DFS.
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 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 within the past 6 months
- •Clinical stage T1-2c
- •Combined Gleason score 2-6
- •Prostate-specific antigen (PSA) < 10 ng/mL within the past 6 months
- •PSA evaluated at least 10 days after prostate biopsy
- •For patients who received finasteride, PSA evaluated at least 30 after completion of finasteride
- •For patients who received dutasteride, PSA evaluated at least 90 after completion of dutasteride
- •No regional lymph node involvement
- •No distant metastases
- •PATIENT CHARACTERISTICS:
- •Zubrod performance status 0-1
- •No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- •No transmural myocardial infarction within the past 6 months
- •No acute bacterial or fungal infection requiring IV antibiotics
- •No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment
- •No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- •No known AIDS
- •No prior or concurrent lymphomatous/hematogenous malignancy or other invasive malignancy except nonmelanomatous skin cancer or any other cancer for which the patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of the bladder or oral cavity)
- •No other severe, active comorbidity
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior radical prostatectomy or cryosurgery for prostate cancer
- •No prior hormonal therapy, including any of the following:
- •Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
- •Antiandrogens (e.g., flutamide or bicalutamide)
- •Estrogens [e.g., diethylstilbestrol (DES)]
- •Surgical castration (bilateral orchiectomy)
- •No prior pelvic radiotherapy or prostate brachytherapy
- •No prior or concurrent cytotoxic chemotherapy for prostate cancer
- •At least 30 days since prior finasteride
- •At least 90 days since prior dutasteride
- •No concurrent neoadjuvant or adjuvant hormonal therapy
- •Concurrent warfarin or other blood-thinning agents allowed
排除标准
- 未提供
研究组 & 干预措施
Hypofractionated 3D-CRT
Experimental
Hypofractionated 3D-CRT or IMRT to 70 Gy in 28 fractions
干预措施: Hypofractionated 3D-CRT or IMRT (Radiation)
Conventional 3D-CRT
Active Comparator
Conventional 3D-CRT or IMRT to 73.8 Gy in 41 fractions
干预措施: Conventional 3D-CRT or IMRT (Radiation)
结局指标
主要结局
Five-year Disease-free Survival (DFS) Rate
时间窗: Analysis occurs after all patients have been followed for five years.
Five-year rates are estimated by the Kaplan-Meier method. DFS events included local progression, distant metastatic progression, biochemical recurrence as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, or death from any cause. Patients who experienced second primary cancers remained under observation for DFS events.
次要结局
- Five-year Local Progression Rate(Analysis occurs after all patients have been followed for five years.)
- Five-year PSA Failure Rate(Analysis occurs after all patients have been followed for five years.)
- Frequency of Patients With GU and GI Acute and Late Toxicity(Acute toxicity is measured from start of treatment to 90 days from the completion of treatment. Late toxicity is defined as toxicity occuring after 90 days from completion of treatment. Analysis occured at the time of the primary endpoint analysis.)
- The Utilization of Sexual Medications/Devices Questionaire(Baseline, 6, 12, and 24 months, and 5 years)
- Assessment of Trade-off Between Disease-free Survival and Quality of Life.(From baseline to 5 years from the start of treatment)
- Five-year Disease-specific Survival Rate(Analysis occurs after all patients have been followed for five years.)
- Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25(Baseline, 6 months, 12 months, 24 months, and 5 years)
- EQ-5D Scores(Baseline, 6 months, 12 months, 24 months, and 5 years)
- Statistical Modeling of Genomic Biomarkers(Baseline biomarker collection. Analysis would occur after the primary endpoint analysis.)
- Five-year Overall Survival Rate(Analysis occurs after all patients have been followed for five years.)
- Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC(Baseline, 6, 12, and 24 months, and 5 years)
研究者
研究点 (296)
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