Botulinum toxin type A for Rectal cancer

Inclusion criteria

• {"criterion_text":"-1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures"}
• {"criterion_text":"-2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)"}
• {"criterion_text":"-3. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner."}
• {"criterion_text":"-4. Candidates scheduled for elective restorative total mesorectal excision for rectal cancer."}

Exclusion criteria

• {"criterion_text":"-1. Partial Mesorectal Excision (PME) and local excision"}
• {"criterion_text":"-2. Resection beyond TME"}
• {"criterion_text":"-3. T4 requiring pelvic exenteration"}
• {"criterion_text":"-4. Inflammatory Bowel Disease (IBD)"}
• {"criterion_text":"-5. If applicable: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive"}
• {"criterion_text":"-6. Participation in an interventional Trial with an investigational medicinal product (IMP) or device"}
• {"criterion_text":"-7. Temporary or permanent stoma"}
• {"criterion_text":"-8. Known hypersensitivity to botulinum toxin type A or to any of its excipients."}
• {"criterion_text":"-9. Presence of infection at the proposed injection site."}
• {"criterion_text":"-10. Known neuromuscular junction disorders such as myasthenia gravis or Lambert-Eaton syndrome."}

Primary endpoints

• {"endpoint_text":"-Primary endpoint: Difference in LARS score between BoNTA and placebo groups at 3 months.","definition_or_measurement_approach":"Difference in LARS score between BoNTA- and placebo-treated groups measured at 3 months post-surgery."}

Secondary endpoints

• {"endpoint_text":"-\tSecondary endpoints: Clinical assessments at 1, 3, and 6 months; patient-reported outcomes (LARS, Wexner, EORTC QLQ-C30 and QLQ-CR29); episodes of urgency/fragmented defecation; colonic manometry parameters; adverse events.","definition_or_measurement_approach":"Clinical assessments at 1, 3, and 6 months; patient-reported outcome measures including LARS, Wexner, EORTC QLQ-C30 and QLQ-CR29; frequency/episodes of urgency or fragmented defecation; measurement of colonic manometry parameters; monitoring and recording of adverse events."}

Belgium

Earliest CTIS Part Ii Submission Date

16-03-2026

Latest Decision Or Authorization Date

02-04-2026

Processing Time Days

17

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium