Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT03315351
Eligibility Criteria:
Inclusion Criteria:
* Patient suffering from a cervical cancer:
* squamous-cell carcinoma or adenocarcinoma histologically proven
* classified from FIGO 2009 IB2 to IVA stage
* Age ≥ 18 years old
* Examination by PET-scan and pelvic RMI realized at diagnosis
* Examination by negative PET-scan remotely closed and at lymph node level
* Surgical lymphadenectomy negative at paraaortic level
* Treatment by external radiotherapy (doses between 45 Gy and 50.4 Gy in 1.8 Gy/fractions) and concomitant chemotherapy (at least 4 cures per weeks using platinum salt) done
* Scheduled curative treatment by brachytherapy driven by RMI
* Affiliation to the National Social Security System
* With informed and signed consent before any procedure specific to the study
Exclusion Criteria:
* Performance status of WHO score \> 2
* Other histology than squamous cell carcinoma or adenocarcinoma
* Metastatic patient or paraaortic node positive
* Adjuvant radiochemotherapy after the first surgery
* Dementia or psychiatric history
* Kidney failure
* Diabet
* Chronic inflammatory bowel disease
* Pelvic and/or vesicoureteral surgery history
* Pelvic irradiation history
* Other active neoplasia or \< 5 years old, except for basocellular carcinoma that can be locally treated
* Contraindication to one of the following procedure : RMI, PET-scan, general anesthesia
* Radiosensitive disease (Fragile X syndrome, Huntington's chorea, Xeroderma Pigmentosum, connective tissue disease) or signs of radiosensitivity.
* Treatment with palliative intent
* Pregnant or breastfeeding women
* Patient Under guardianship or tutorship
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03315351
Study Brief:
Protocol Section:
NCT03315351