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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT04864067
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of adenocarcinoma of the rectum
* Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on Magnetic Resonance Imaging (MRI)
* Tumors \< 7cm from anal verge (palpable)
* No prior history of rectal cancer
Exclusion Criteria
* Patients with tumors \>7cm from anal verge
* ECOG \>1,
* Contraindication for chemotherapy: Hemoglobin \<8, White Blood Count \<4000, Platelets \<100,000, Creatinine Clearance \<50ml/min, Total Bilirubin \<5mg/dl,
* Stage IV at diagnosis
* Coronary artery disease, either no treated or recent acute coronary syndrome in the last 12 months.
* Congestive heart failure
* Peripheral neuropathy
* Previous pelvic radiotherapy
* Prior rectal cancer treatment
* Pregnancy or nursery
* Any contraindications to MRI (e.g. patients with pacemakers)
* Indication of pelvic exenteration
* Impossibility to consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04864067
Study Brief:
Protocol Section:
NCT04864067