TerminatedNot Applicable

Study of a Predictor for Cervix Cancer

Stopped: unreached recruitment objectives

France9 participantsStarted 2012-01

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

change from baseline of value of persisting hypoxia at day 14

Timeframe: Baseline, Day 14

Trial details

NCT IDNCT01641484

SponsorCentre Oscar Lambret

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12