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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT01257035
Eligibility Criteria:
Inclusion Criteria:
* Histopatologically verified adenocarcinoma in the rectum
* T4 tumor eller T3 tumor \< 10 cm from the anus and \< 5 mm from the mesorectal fascie measured by MR scan. At the distal part of the rectum the distance to the mesorectal fascie is \< 5 mm and therefore all T3 tumors are included in this area
* Suitable for preoperative radiation and chemotherapy
* No distant metastases
* Age \>18 years
* Hematology ANC ≥1.5x10\^9/l. Thrombocytes ≥ 100x10\^9/l.
* Biochemistry Bilirubin ≤ 3 x UNL. ALAT ≤ 5 x UNL
* Creatinine ≤ UNL
* Contraception for fertile women
* Written and orally informed consent
Exclusion Criteria:
* Other malignant disease within 5 years, excl. non-melanotic skin cancer
* Previous radiation treatment of the pelvis
* Pregnant or breastfeeding women
* Surgery within 6 weeks prior to enrollment
* Serious concurrent medical disease
* Enrollment in study "A prospective observational study of patients with rectum cancer after concomitant radiation and chemotherapy", where the patients are potientially not operated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01257035
Study Brief:
Protocol Section:
NCT01257035