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:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT01648894
Eligibility Criteria:
Inclusion Criteria:
* age over 18 years, no age limit higher
* Performance status evaluated by the Eastern CooperativeOncology Group (ECOG) score: 0-1,
* Patients with cancer of the middle or lower rectum (lesion located within 10 cm from the dentate line or 12 cm from the anal margin) proved by pathology,
* T3-T4N0, TxN+ on ultrasound-endoscopy and MRI, without secondary localization (M0) on the thoracoabdominal (or chest radiography and abdominal ultrasound)
* Patient who received a protocol between 45-51 Gy of radiotherapy and chemotherapy based on 5-fluorouracil for an average duration of 5 weeks for the management of rectal cancer,
* Curative surgical treatment planned following radiochemotherapy with total mesorectal excision,
* Free and informed consent signed by the patient,
* Patient affiliated to a social security scheme or beneficiary of such plan(except AME)
* Patient able, according to the investigator, to comply with the requirements of the study.
The cessation of chemotherapy during radiotherapy does not exclude the patient from the study.
Exclusion Criteria:
* Patient with metastasis,
* T1 or T2N0 tumor classified by echo-endoscopy and MRI,
* rectal tumor with lower pole is more than 12 cm from the anal margin or 10 cm from the dentate line,
* Patient did not complete the full protocol of radiotherapy,
* History of tumors (other than basal cell carcinoma and / or carcinoma in situ of the cervix) old less than 10 years
* A patient with impaired or incompetent investigator by not allowing him a good understanding of the requirements of the study,
* Person under guardianship, persons under guardianship, persons deprived of their liberty by judicial or administrative body, adult subject to legal protection or unable to consent,
* Patient did not complete the full protocole of chemotherapy,
* Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01648894
Study Brief:
Protocol Section:
NCT01648894