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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- change from baseline of value of persisting hypoxia at day 14
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •cervix epidermoid cancer or adenocarcinoma : I to IIIB
- •treatment by radiochemotherapy
- •social and psychological compliance for standard treatment of radiochemotherapy for cervix carcinoma
- •patient affiliated to health insurance system
- •signed informed consent
排除标准
- •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
研究组 & 干预措施
local control 19.8Gy
local control at 19.8 Gy, at Day 14
干预措施: local control at 19.8Gy (Procedure)
结局指标
主要结局
change from baseline of value of persisting hypoxia at day 14
时间窗: Baseline, Day 14
dynamic MRI : tumor volume, intensity of contrast enhancement (Ktrans and SI10 measurement) TEP scan : metabolic intensity, SUV measurement comparison of biopsie negativity
次要结局
- impact of tumor hypoxia on necrosis appearance(Day 45 and Day 120)
- safety(baseline, Day 14, Day 45, Day 120)
- MRI and TEP local control evaluation(4 months)
- correlation between biomarkers of tumor hypoxia evolution and local control(baseline, Day 14, Day 45 and Day 120)