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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07483060
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Written informed consent
* Biopsy-proven rectal adenocarcinoma
* Tumor located \<12 cm from the anal verge
* MRI-staged T1-T3b tumor
* N0 or NX (no radiologic evidence of nodal metastases)
* M0 or MX (no radiological evidence of distant metastases)
* ECOG performance status 0-1
* Multidisciplinary team (MDT) assessment confirming that both total mesorectal excision (TME) and chemoradiotherapy are feasible treatment options
Exclusion Criteria:
* MRI-defined N1 or higher nodal disease
* Distant metastases (M1)
* MRI extramural vascular invasion (mriEMVI)
* Threatened mesorectal fascia (≤1 mm on MRI)
* Maximum tumor diameter \> 40 mm
* MRI defined mucinous tumor
* No residual luminal tumor following prior endoscopic resection
* Recurrent rectal cancer
* Prior pelvic radiotherapy
* Uncontrolled significant cardiorespiratory comorbidity
* Known complete dihydropyrimidine dehydrogenase (DPYD) deficiency
* Known Gilbert's syndrome
* Pregnancy or breastfeeding
* Concomitant medication contraindicated with capecitabine that cannot be safely discontinued
* Age \<18 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07483060
Study Brief:
Protocol Section:
NCT07483060