Study of a Predictor for Cervix Cancer (ANOXICOL)

Centre Oscar Lambret

Status: Terminated

Conditions: Oncology; Cervix Cancer

Treatments: Procedure: local control at 19.8Gy

Study type: Interventional

Funder types: Other

Identifiers

NCT01641484

ANOXICOL-1102

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

local control 19.8Gy

Experimental group

Description:

local control at 19.8 Gy, at Day 14

Treatment:

Procedure: local control at 19.8Gy