Hypofractionated Radiotherapy for Prostate Cancer (62 Gy in 20 Fractions of 3.1 Gy) With Hyaluronic Acid Injection
试验速览
- 阶段
- 2 期
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Number of patients with late rectal toxicities (> 3 months) of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate.
研究概览
简要总结
The present Phase II study aims to assess the rates of late rectal toxicities of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate. Thirty-six patients with a low- to intermediate-risk prostate cancer according to the D'Amico classification are included in the present protocol. The main characteristics of the study are that the patients benefit of a reduction of the treatment duration from 40 to 20 fractions, due to the hypofractionated irradiation, and of an injection of 3 to 10 cc of hyaluronic acid in the perirectal fat between the rectum and the prostate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •age superior or equal to 18 years and inferior to 80 years.
- •patient with a low- to intermediate-risk prostate cancer, according to D'Amico classification, for an exclusive irradiation.
- •prostate cancer histologically proven.
- •life expectancy superior to 10 years.
- •Karnofsky performance status ≥ 60% (performance status ECOG 0-2).
- •the patient has to be the beneficiary of a social security system or other insurance (order n° 2006-477 from April 26th 2006).
- •the signed consent form.
排除标准
- •age inferior to 18 years and ≥ 80 years;
- •history of rectal surgery;
- •patient who can't cooperate during the treatment;
- •history of pelvic irradiation;
- •history of inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;
- •other current neoplasia or history of neoplasia dating from less than 5 months, excepting basal-cell carcinomas;
- •patients treated with anti-neoplastic or anti-angiogenic or with other treatments used in rheumatology and which may include methotrexate (in order not to have a radiosensitizing effect);
- •patients receiving anticoagulant treatment or PLAVIX;
- •other undergoing study that may interfere with the present study;
- •patient under legal protection measure.
结局指标
主要结局
Number of patients with late rectal toxicities (> 3 months) of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate.
时间窗: Follow-up at 3 months and 6 months after the radiotherapy and then every 6 months up to 3 years.
Late rectal toxicities of grade ≥ 2 assessed using the CTCAE v 4.0 classification from 3 months to 3 years.
次要结局
- Number of patients with acute rectal toxicities of all grades and of grade ≥ 2.(3 years)
- Number of patients with acute and late toxicities, other than the rectal toxicities.(3 years)
- Tolerance of the HA injection(3 years)
- The evaluation of the biochemical control(3 years: evaluation at 3 months, 6 months and then every 6 months during the 3 years.)