Study of a Predictor for Cervix Cancer (ANOXICOL)

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

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

Study Overview

• Status: Terminated
• Conditions: Cervix Cancer; Oncology
• Intervention / Treatment: Procedure: local control at 19.8Gy

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59020
    • Oscar Lambret Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: local control 19.8Gy; local control at 19.8 Gy, at Day 14	Procedure: local control at 19.8Gy; Day 14, full body TEP and pelvis MRI

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Investigators: Principal Investigator: Nickers Philippe, MD, Centre Oscar Lambret

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: July 6, 2012
• First Submitted That Met QC Criteria: July 12, 2012
• First Posted (Estimated): July 16, 2012

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: ANOXICOL-1102; 2011-A00237-34 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO