Transanal endoscopic microsurgery (TEM) and Radiotherapy in Early rectal Cancer

Phase 2

Completed

• Conditions: Early rectal cancer; Cancer; Malignant neoplasm of rectum

• Registration Number: ISRCTN14422743
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33308452/ results (added 16/12/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36403589/ Quality of life (added 21/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-09
• Study Completion: 2011-12-01
• Last Update Posted: 5 December 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Biopsy proven adenocarcinoma
2. MRI defined stage I rectal cancer (less than or equal to pT2 N0)
3. Endorectal ultrasound defined rectal cancer less than or equal to uT2
4. Patients who have undergone submuscosal excision for a presumed villous adenoma that on histopathological examination contains discrete invasion less than 3 cm diameter
5. Aged 18 or over, either sex

Exclusion Criteria

1. Familial/genetic cancer
2. T3+ or nodal involvement on radiological staging
3. Contraindications to radiotherapy
4. Previous pelvic radiotherapy
5. Metastatic disease
6. Unable or unwilling to provide written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified