Clinical trial NCT01641484: Study of a Predictor for Cervix Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervix Cancer
Oncology
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-07-16
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: change from baseline of value of persisting hypoxia at day 14
timeFrame: Baseline, Day 14
Secondary outcomes:
measure: safety
timeFrame: baseline, Day 14, Day 45, Day 120
measure: MRI and TEP local control evaluation
timeFrame: 4 months
measure: impact of tumor hypoxia on necrosis appearance
timeFrame: Day 45 and Day 120
measure: correlation between biomarkers of tumor hypoxia evolution and local control
timeFrame: baseline, Day 14, Day 45 and Day 120
Other outcomes:
Locations:
city: Lille
country: France
facility: Oscar Lambret Center
Study officials:
affiliation: Centre Oscar Lambret
name: Nickers Philippe, MD
role: PRINCIPAL_INVESTIGATOR
References: