Study of a Predictor for Cervix Cancer (NCT01641484) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
FEMALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change from baseline of value of persisting hypoxia at day 14