Study of a Predictor for Cervix Cancer

NCT ID: NCT01641484

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-02-28

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.

Conditions

Cervix Cancer; Oncology

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

local control 19.8Gy

local control at 19.8 Gy, at Day 14

Group Type: EXPERIMENTAL

local control at 19.8Gy

Intervention Type: PROCEDURE

Day 14, full body TEP and pelvis MRI

Interventions

local control at 19.8Gy

Day 14, full body TEP and pelvis MRI

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nickers Philippe, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

Oscar Lambret Center

Lille, , France

Countries

France

Other Identifiers

ANOXICOL-1102

Identifier Type: -

Identifier Source: org_study_id