Phase I Study Evaluating Extended Field Intensity Modulated Radiation Therapy and Docetaxel in Patients With Prostate Cancer Associated With Pelvic Node Metastasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Toxicity rate
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. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and bicalutamide, may lessen the amount of androgens made by the body. Giving radiation therapy together with chemotherapy and hormone therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with intensity-modulated radiation therapy and hormone therapy in treating patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis.
详细描述
OBJECTIVES:
Primary
- Determine, preliminarily, the grade III or IV toxicity rate of concurrent extended-field intensity-modulated radiotherapy (IMRT), docetaxel, and androgen deprivation therapy in patients with high-risk, locally advanced prostate cancer with pelvic lymph node metastasis.
Secondary
- Determine, preliminarily, the progression-free survival of patients treated with this regimen.
- Determine the maximum tolerated dose of docetaxel when administered with concurrent IMRT in this patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate
- •o Locally advanced disease (T1 -T3b, N1 or N2, M0) at high risk for recurrence
- •Biopsy-proven pelvic lymph node involvement
- •No T4 lesion
- •Prior androgen suppression within the past 14 months is allowed provided the following criterion is met:
- •o No biochemical evidence of PSA progression after androgen withdrawal
- •PSA progression, defined as 2 consecutive rising PSA values > 4.0 ng/mL taken ≥ 2 weeks apart
- •Karnofsky performance status 80-100%
- •absolute neutrophil count (ANC) ≥ 1,500/mm³
- •Hemoglobin ≥ 10 g/dL
- •Platelet count > 100,000/mm³
- •Bilirubin normal
- •Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- •Meets 1 of the following criteria:
- •Alkaline phosphatase (AP) normal and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN)
- •AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- •AP ≤ 5 times ULN AND AST or ALT normal
排除标准
- •No evidence of distant metastasis, including any of the following:
- •Bone metastasis
- •Pathologic or radiographic evidence of lymph node involvement above the L4 - L5 interspace
- •No peripheral neuropathy > grade 1
- •No significant comorbidity that would preclude radiotherapy
- •No other prior malignancy except nonmelanoma skin cancer or any other cancer for which the patient has been disease-free for the past 5 years
- •No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
- •No history of Crohn's disease, ulcerative colitis, or irritable bowel syndrome
- •No unrepaired inguinal hernia
- •No prior pelvic or abdominal radiotherapy or prostate brachytherapy implant
- •No prior prostatectomy
- •No prior pelvic or abdominal surgery that resulted in excessive amounts of small intestine located within the pelvis
- •No other concurrent investigational agents
研究组 & 干预措施
Docetaxel, intensity-modulated radiation therapy and hormone therapy
This phase I trial is studying the side effects and best dose of docetaxel when given together with intensity-modulated radiation therapy and hormone therapy in treating patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis.
干预措施: bicalutamide (Drug)
Docetaxel, intensity-modulated radiation therapy and hormone therapy
This phase I trial is studying the side effects and best dose of docetaxel when given together with intensity-modulated radiation therapy and hormone therapy in treating patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis.
干预措施: docetaxel (Drug)
Docetaxel, intensity-modulated radiation therapy and hormone therapy
This phase I trial is studying the side effects and best dose of docetaxel when given together with intensity-modulated radiation therapy and hormone therapy in treating patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis.
干预措施: goserelin (Drug)
Docetaxel, intensity-modulated radiation therapy and hormone therapy
This phase I trial is studying the side effects and best dose of docetaxel when given together with intensity-modulated radiation therapy and hormone therapy in treating patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis.
干预措施: intensity-modulated radiation therapy (Radiation)
结局指标
主要结局
Toxicity rate
时间窗: during therapy and follow-up, & for 5 years after radiation is completed
Toxicity rate as assessed by NCI CTCAE v3.0
次要结局
- Progression-free survival(From start of therapy up to 5 years after radiation is complete)
- Maximum tolerated dose (MTD) of docetaxel(From start of therapy up to 5 years after radiation is complete)