Clinical trial · Interventional
Study of a Predictor for Cervix Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): unreached recruitment objectives
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Cancer | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| local control at 19.8Gy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- local control 19.8Gy
- description
- local control at 19.8 Gy, at Day 14
- interventionNames
- Procedure: local control at 19.8Gy
Primary outcomes (1)
- measure
- change from baseline of value of persisting hypoxia at day 14
- timeFrame
- Baseline, Day 14
- description
- dynamic MRI : tumor volume, intensity of contrast enhancement (Ktrans and SI10 measurement) TEP scan : metabolic intensity, SUV measurement comparison of biopsie negativity
Secondary outcomes (4)
- measure
- safety
- timeFrame
- baseline, Day 14, Day 45, Day 120
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available