Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer of 70 Years Old Women : Contribution of Oncogeriatric Evaluation to the Study of Acute Toxicity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 14
- 主要终点
- change from baseline in acute toxicity all along the radiation
研究概览
简要总结
Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years with a endometrial cancer.
详细描述
Endometrial cancer is the most common form of gynecological cancer in France with 6560 new cases in 2010. Endometrial cancers occurs generally after menopause but are sometimes diagnosticated before 40 years. The 5 years Overall survival of endometrial cancer is 76% (95% for non locally advanced or non metastatic disease).
Some factors are involved in disease prognostic: age, geographical origin, physical status, tumor grade, tumor histology and probably biomarkers. Some studies demonstrated that advanced age is a negative prognostic factor due to higher relapse risk and higher specific mortality. Unfortunately, Incidence of endometrial cancer will probably increase in future due to aging of the occidental population.
Current treatment of endometrial cancer is based on post-operative radiation therapy: adjuvant brachytherapy or adjuvant external beam radiation therapy. However these techniques lead to serious toxicity (digestive toxicity, ileitis...) in elder patient. Consequently, pelvic radiation therapy is difficult to organize before 75 years and dangerous to perform after 80 years.
However a new technique called: Intensity-modulated radiation therapy (IMRT) can make the difference. IMRT is a new high precision radiotherapy technique probably well adapted for old people, with less toxicity than current radiotherapy.
Nevertheless, IMRT is not recognized as a standard radiation therapy procedure in France and Europe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •endometrial adenocarcinoma histologically proven
- •post op pelvic radiotherapy
- •performance status ≤ 2
- •MMSE ≥ 10
- •life expectancy ≥ 3 months
- •social security covered
- •signed informed consent
排除标准
- •type I stade IAGI and stade IAGIII without myometer infiltration, stade IIIc2 and IV adenocarcinoma
- •uterine sarcoma
- •surgery not in accordance with recommendations of Inca
- •previous uncontrolled or less than 5 years prior to diagnosis cancer
- •cons-indication for radiotherapy
- •diarrhea ≥ 3 per day
- •pelvic lymph nodes > 1cm not resected during staging
- •previous sigmoid diverticulitis, crohn disease, systemic disease, ulcerative haemorrhagic, collagenosis, infectious peritonitis
- •IMRT other than tomotherapy
- •photon energy < 10MV
- •patient under guardianship
研究组 & 干预措施
3D conformational radiotherapy
25 * 1.8 Gy in 5 weeks (=45 Gy). 3D conformational radiation
干预措施: 3D conformational radiation (Radiation)
Intensity-Modulated Radiation Therapy
25 * 1.8 Gy in 5 weeks (=45 Gy). IMRT
干预措施: IMRT (Radiation)
结局指标
主要结局
change from baseline in acute toxicity all along the radiation
时间窗: baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 Week after end of treatment, 8 Weeks after end of treatment
NCI CTCAE v 4.0 tox \> grade 2 will be compared
次要结局
- geriatric repercussion(baseline, 6 months after end of treatment)
- geriatric intervention(up to 6 months)
- quality of life(baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 week and 8 weeks after end of treatment, 6, 12, 18 and 24 months after end of treatment)
- late major toxicity(1 week, 8 weeks, 6, 12, 18 and 24 months after the end of treatment)
- progression free survival(an average period of 2 years)
- duration of the radiation(up to 5 weeks and a half)