FARE Trial

Phase 1

• Conditions: Rectal cancer; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: CTIS2023-506594-35-00
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-27
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Group A: Patients aged =18 years with suspected or confirmed cT1-3N0-1M0 rectal cancer, defined as tumour invasion not extending beyond the perirectal tissue on standard MRI, with or without evidence of locoregional LNM on MRI, and no evidence of distant metastases on chest and abdominal CT., Group A: Scheduled for primary TME (i.e. without prior local excision and without neo-adjuvant treatment)., Group A: Approval of the local multidisciplinary colorectal tumour board for performing primary TME., Group B: Patients aged =18 years with suspected or confirmed cT1-2N0M0 rectal cancer, defined as tumour invasion not beyond the muscularis propria on standard MRI, no evidence of LNM on MRI, and no evidence of distant metastases on chest and abdominal CT., Group B: Tumours with endoscopic features of deep submucosal/muscularis propria invasion defined as: NBI: Hiroshima C2/3, JNET 3, NICE III, or chromoendoscopy: Kudo Vn pit pattern and/or the presence of non-lifting in the presence of features of submucosal invasion (Hiroshima C1, JNET 2B, Kudo Vi pit pattern), thus a tumour suitable for local excision., Group B: Planned local excision using either EID or TAMIS., Group B: Approval of the local multidisciplinary colorectal tumour board for performing (diagnostic) local excision.

Exclusion Criteria

Group A & B: Not able to communicate in Dutch or English, Group A & B: Neoadjuvant treatment (for current diagnosis of rectal cancer), Group A & B: Pregnant (either the patient or someone in the same household) or lactating women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified