Study of a Predictor for Cervix Cancer (ANOXICOL)
Study Evaluating Predictive Value of Local Control at 19.8 (MRI and TEP Scan) for Patient With Stade I to IIIB Cervix Carcinoma Treated by Radiotherapy
Non operated cervix cancer are usually treated by radio-chemotherapy. Non control local rate is inexplicably close to 30%. However, important volume of those tumors and their hypoxia degree induce phenomenon of pathologic angiogenesis, explaining these therapeutic failures.
Persistence of tumor hypoxia could be a predictive factor of local control
研究概览
详细说明
HPV linked cervix cancer is the second most prevalent form of female cancer. It's also the leading cause of death by cancer in Asia, South America and Africa. Hopefully, screening program lead to a 50 % of mortality reduction during the past 40 years. Classic therapeutic strategy consists of external pelvic radiation therapy associated with chemotherapy and followed by brachytherapy. Curative surgical removal is realized 4 to 6 weeks after radiation therapy. However relapse rate is frequent (20 to 30%). Biological mechanisms involved in this high relapse rate are not understood.
Nevertheless, it is suggest that initial hypoxia of cervix tumor during 20 Gy radiation therapy is a pejorative prognostic factor. At the opposite, the amelioration of tumor vascularisation during 20 Gy radiation therapy is a positive prognostic factor. It's possible that an amelioration of hypoxia lead to lesser tumor resistance to radiotherapy. However such possibility has to be test during clinical trial.
Thus, the objective of ANOXICOL study is to evaluate the predictive value of persistent hypoxia, during 20 Gy radiation therapy associated with chemotherapy, for local control of cervix cancer.
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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Lille、法国、59020
- Oscar Lambret 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:
- cervix epidermoid cancer or adenocarcinoma : I to IIIB
- treatment by radiochemotherapy
- ECOG ≤ 1
- social and psychological compliance for standard treatment of radiochemotherapy for cervix carcinoma
- patient affiliated to health insurance system
- signed informed consent
Exclusion Criteria :
- contraindication to chemoradiotherapy
- resequable cervical cancer
- para-aortic metastases histologically proven
- inability to perform an abdominal MRI or a PET Scan
- contraindications related to MRI: pacemaker, vascular clip, and all devices incompatible with the electromagnetic field generated by MRI
- unbalanced diabete
- administration of EPO
- transfusion within 3 days before the first biopsy
- creatinine clearance under 60 mL / min;
- ANC <1500 / mm3 and Platelets <120,000 / mm3
- neuropathy, diabetes (fasting glucose greater than 140 mg / l) or any other condition that strongly contraindicates concomitant chemotherapy with radiotherapy
- sigmoid diverticulitis, Crohn's disease or systemic disease, collagenose
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：local control 19.8Gy
local control at 19.8 Gy, at Day 14
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Day 14, full body TEP and pelvis MRI
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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 |
|---|---|---|
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change from baseline of value of persisting hypoxia at day 14
大体时间：Baseline, Day 14
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dynamic MRI : tumor volume, intensity of contrast enhancement (Ktrans and SI10 measurement) TEP scan : metabolic intensity, SUV measurement comparison of biopsie negativity
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Baseline, Day 14
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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safety
大体时间：baseline, Day 14, Day 45, Day 120
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NCI CTCAE v 4.0
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baseline, Day 14, Day 45, Day 120
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MRI and TEP local control evaluation
大体时间：4 months
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4 months
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impact of tumor hypoxia on necrosis appearance
大体时间：Day 45 and Day 120
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necrosis quantification from biopsies
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Day 45 and Day 120
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correlation between biomarkers of tumor hypoxia evolution and local control
大体时间：baseline, Day 14, Day 45 and Day 120
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evaluate necrosis appearance as a proxy to local control
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baseline, Day 14, Day 45 and Day 120
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合作者和调查者
调查人员
- 首席研究员：Nickers Philippe, MD、Centre Oscar Lambret
研究记录日期
研究主要日期
学习开始
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
local control at 19.8Gy的临床试验
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University of British ColumbiaPacific Alzheimer Research Foundation完全的