Study of a Predictor for Cervix Cancer

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Oncology, Cervix Cancer

Intervention / Treatment
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* Procedure: local control at 19.8Gy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: local control 19.8Gy<br>local control at 19.8 Gy, at Day 14 | Procedure: local control at 19.8Gy<br>* Day 14, full body TEP and pelvis MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline of value of persisting hypoxia at day 14 | dynamic MRI : tumor volume, intensity of contrast enhancement (Ktrans and SI10 measurement) TEP scan : metabolic intensity, SUV measurement comparison of biopsie negativity | Baseline, Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | NCI CTCAE v 4.0 | baseline, Day 14, Day 45, Day 120 | 
| MRI and TEP local control evaluation |  | 4 months | 
| impact of tumor hypoxia on necrosis appearance | necrosis quantification from biopsies | Day 45 and Day 120 | 
| correlation between biomarkers of tumor hypoxia evolution and local control | evaluate necrosis appearance as a proxy to local control | baseline, Day 14, Day 45 and Day 120 |