Selective Neoadjuvant Therapy of Rectal Cancer Patients: SELREC - a randomized controlled, open, multicentre non-inferiority trial

Not Applicable

Recruiting

• Conditions: C20; Malignant neoplasm of rectum

• Registration Number: DRKS00030567
• Lead Sponsor: niversitätsklinikum Heidelberg; Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1074

Inclusion Criteria

Primary adenocarcinoma of the rectum <12cm from the anal verge
- T3 and/or N1 disease
- CRM >1mm (MRI based)
- No evidence of distant metastasis (M0)
- Age =18 years
- Ability of patient subject to understand character and individual consequences of the clinical trial
- Written informed consent

Exclusion Criteria

- Patients who should not receive multimodal treatment for safety reasons
- Patients needing neoadjuvant treatment for sphincter preservation
- Previous radiotherapy to the small pelvis
- Patients with extensive lymph node spread (N2)
- Extramural vascular invasion or tumour deposits
- Participation in another interventional trial with interference of intervention and/or outcome of this trial
- Previous diagnosis of malignant disease except basal cell carcinoma
- Contraindications for MRI (e.g. non-MRI-compatible cardiac pacemaker)
- Pregnancy or lactation
- Any condition that could result in an undue risk for the patient based on the investigator’s assessment

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocal recurrence within three years after surgery

Secondary Outcome Measures

Name	Time	Method
major low anterior resection syndrome (LARS), overall survival, perioperative morbidity, perioperative mortality, quality of life, functional socres (urinary and sexual)