Study of a Predictor for Cervix Cancer

NCT01641484 | Terminated

• 2 other identifiers: ANOXICOL-11022011-A00237-34
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

Cervix Cancer; Oncology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• safety

  baseline, Day 14, Day 45, Day 120

• MRI and TEP local control evaluation

  4 months

• impact of tumor hypoxia on necrosis appearance

  Day 45 and Day 120

• correlation between biomarkers of tumor hypoxia evolution and local control

  baseline, Day 14, Day 45 and Day 120

Study Arms (1)

local control 19.8Gy

EXPERIMENTAL

local control at 19.8 Gy, at Day 14

Procedure: local control at 19.8Gy

Interventions

local control at 19.8Gy PROCEDURE

Day 14, full body TEP and pelvis MRI

local control 19.8Gy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (1)

Oscar Lambret Center

Lille, 59020, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Nickers Philippe, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 16, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)