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 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT06087718
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age and capable of giving informed consent.
* Adenocarcinoma of the rectum classified cT (clinical Tumor) 2-3b, \< 5 cm largest diameter and \< ½ circumference (MRI staging), N0-N1 (any node \< 8 mm diameter), M0
* Operable patient
* Tumor accessible to the Maastro applicator with a distance from the lower tumor border to the anal verge ≤10 cm
* No comorbidity preventing treatment
* Adequate birth control for women of child-bearing potential
* Follow-up possible.
Exclusion Criteria:
* Tumor extending into the anal canal.
* Stop of anti-coagulants (except ≤100 mg aspirin/day) is medically contraindicated.
* Presence of coagulation disorder resulting in an increased bleeding risk.
* Prior pelvic radiation therapy (excluding the abovementioned neoadjuvant treatment).
* Prior surgery or chemotherapy for rectal cancer (excluding the abovementioned neoadjuvant treatment).
* Inflammatory bowel disease (IBD).
* (Systemic) treatment possibly causing rectal or genitourinary toxicity for a separate active malignancy.
* World Health Organization performance status (WHO-PS) ≥ 3.
* Life expectancy of \< 6 months.
* Pregnant women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06087718
Study Brief:
Protocol Section:
NCT06087718