A Phase I Dose Escalation Study of Hypofractionated Accelerated Pelvic Nodal Radiotherapy Delivered With A Simultaneously Integrated Prostate Boost For Patients With Localized, Intermediate- And High-Risk Prostate Cancer (GCC 2048)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- HypoFx RT schedule that results in <33% acute dose-limiting toxicity with accelerated, HypoFx pelvic nodal RT
研究概览
简要总结
A phase I trial to determine the safety of delivering three sequentially shorter RT schedules (20, 16, and 12 fractions) of HypoFx pelvic nodal RT in combination with a HypoFx, simultaneous integrated boost (SIB) to the prostate that have been designed to incrementally increased the biological equivalent dose (BED) to prostate cancer, while maintaining a constant BED to normal tissue toxicity.
详细描述
Outcomes for patients with unfavorable intermediate-risk and high-risk prostate cancer (PC) have been historically poor and are now known to require multimodality treatment. A standard non-surgical treatment option for patients with localized, intermediate and high-risk PC is radiation therapy (RT) in combination with short- or long-term androgen deprivation therapy (ADT).
The benefit of pelvic nodal RT in this setting is unclear, previous studies have been equivocal. There is a growing body of evidence to demonstrate that use of hypofractionated (HypoFx) RT may be a safe method for increasing the dose of RT, while also decreasing normal tissue toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient age is ≥ 18 years
- •Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration.
- •Patient's with intermediate to high risk prostate cancer and must be recommended to undergo pelvic as well as prostatic irradiation.
- •History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.
- •Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), (but not by nodal sampling, or dissection) within 120 days prior to registration.
- •Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm.
- •No evidence of bone metastases (M0) on bone scan within 120 days prior to registration.
- •Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.
- •Baseline serum PSA value performed within 12 weeks (90 days) prior to registration.
- •ECOG Performance Status 0-1
- •Patient must be able to provide study specific informed consent prior to study entry.
排除标准
- •Evidence of distant metastases
- •Regional lymph node involvement
- •Previous radical surgery (prostatectomy), cryosurgery, or HIFU (High-intensity focused ultrasound) for prostate cancer
- •Previous pelvic irradiation or prostate brachytherapy
- •Planned prostate brachytherapy boost
- •Previous or concurrent cytotoxic chemotherapy for prostate cancer
- •Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
- •Patients are excluded if they have a history of autoimmune disease that, in the opinion of the treating physician would be a contraindication to pelvic radiation (e.g., active systemic lupus, progressive scleroderma)
- •Patients receiving full-dose anticoagulation or clopidogrel
- •Patients taking 81 mg Aspirin po daily may are still eligible for the study
- •Patients with a history of prior small bowel ulceration
研究组 & 干预措施
Dose Level 1
Dose schedules were calculated to maintain similar BED for late normal tissue injury (α/β= 3.0 Gy), with an increased BED for PC (α/β= 1.5Gy). Patients be treated with 20 fractions. A total of 6 patients will be treated at the dose that is determined to be Maximum Tolerated Dose.
干预措施: Hypofractionated Radiation Therapy (Radiation)
Dose Level 2
Dose schedules were calculated to maintain similar BED for late normal tissue injury (α/β= 3.0 Gy), with an increased BED for PC (α/β= 1.5Gy). Patients be treated with 16 fractions. A total of 6 patients will be treated at the dose that is determined to be Maximum Tolerated Dose.
干预措施: Hypofractionated Radiation Therapy (Radiation)
Dose Level 3
Dose schedules were calculated to maintain similar BED for late normal tissue injury (α/β= 3.0 Gy), with an increased BED for PC (α/β= 1.5Gy). Patients be treated with 12 fractions. A total of 6 patients will be treated at the dose that is determined to be Maximum Tolerated Dose.
干预措施: Hypofractionated Radiation Therapy (Radiation)
结局指标
主要结局
HypoFx RT schedule that results in <33% acute dose-limiting toxicity with accelerated, HypoFx pelvic nodal RT
时间窗: Within 90 days of completing RT
The frequency of all observed acute GI, GU, hematologic, and neurologic dose limiting toxicities by CTCAE v5 grade will be tabulated. DLT is defined as treatment-related: Grade ≥3 GI (small bowel or rectal) toxicity, Grade ≥3 GU toxicity, Grade ≥3 hematologic, Grade ≥3 neurologic toxicity, or any grade 5 treatment-related adverse events.
次要结局
- Dose volume histogram (DVH) parameters(Within 90 days of completing RT)
- Frequency of acute and late GI, GU, hematologic, and neurologic toxicity for each dose cohort(Acute (within 90 days completing RT), Late (occurring > 90 days from treatment), 3-months, 6 months, 1-year and 2 years)
- Evaluate the duration of biochemical progression-free survival(2 years after completing RT)
- Patient Reported Outcomes (PROs) related to urinary function(1 month after completion of treatment, every 3 months for year 1, and every 6 months during Year 2)
- Patient Reported Outcomes (PROs) related to urinary and bowel function(1 month after completion of treatment, every 3 months for year 1, and every 6 months during Year 2)
研究者
Department of Radiation Oncology
Principal Investigator
University of Maryland, Baltimore