Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer (TOMOGYN)
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
研究概览
详细说明
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.
Thus, goal of TOMOGYN study is to compare the tolerance of old women (at least 70 years), with endometrial cancer, treated with external beam radiation therapy or IMRT.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Bordeaux、法国、33076
- Bergonié Institut
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Caen、法国、14076
- François Baclesse Center
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Lille、法国、59020
- Oscar Lambret Center
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Lyon、法国、69373
- Centre Léon Bérard
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Reims、法国、51726
- Institut Jean Godinot
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Saint Herblain、法国、44805
- René Gauducheau Center
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Strasbourg、法国、67065
- Paul Strauss Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- endometrial adenocarcinoma histologically proven
- post op pelvic radiotherapy
- age ≥ 70
- performance status ≤ 2
- MMSE ≥ 10
- life expectancy ≥ 3 months
- social security covered
- signed informed consent
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：3D conformational radiotherapy
25 * 1.8 Gy in 5 weeks (=45 Gy).
3D conformational radiation
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25 * 1.8 Gy in 5 weeks (=45 Gy)
|
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实验性的：Intensity-Modulated Radiation Therapy
25 * 1.8 Gy in 5 weeks (=45 Gy).
IMRT
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25 * 1.8 Gy in 5 weeks (=45 Gy)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change from baseline in acute toxicity all along the radiation
大体时间：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
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baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 Week after end of treatment, 8 Weeks after end of treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
geriatric intervention
大体时间：up to 6 months
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number of intervention, consequences in terms of base treatment change, intervention of other specialists (except cancer)
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up to 6 months
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geriatric repercussion
大体时间：baseline, 6 months after end of treatment
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scales : Activities in Daily Living (ADL), Instrumental Activities in Daily Living (IADL), Mini Nutritionnal Assessment (MNA), Geriatric Depression Scale (GDS), cognitive evaluation, Cumulative Illness RAting Scale-Geriatrics (CIRS-G), sociocultural questionnaire, walking and balance
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baseline, 6 months after end of treatment
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duration of the radiation
大体时间：up to 5 weeks and a half
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interval between first day and last day of treatment
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up to 5 weeks and a half
|
|
quality of life
大体时间：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
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QLQ C30 questionnaire
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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
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late major toxicity
大体时间：1 week, 8 weeks, 6, 12, 18 and 24 months after the end of treatment
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NCI CTCAE v 4.0
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1 week, 8 weeks, 6, 12, 18 and 24 months after the end of treatment
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progression free survival
大体时间：an average period of 2 years
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median time between date of inclusion and date of clinical or radialogical progression
|
an average period of 2 years
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合作者和调查者
调查人员
- 首席研究员：Le Tinier Florence, MD、Centre Oscar Lambret
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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