NCT01308190

Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Total Mesorectal Excision in T2-T3s N0, M0 Rectal Cancer

Prospective Randomized Clinical Trial for no Inferiority With Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery (TEM) Versus Total Mesorectal Excision in T2-T3s N0, M0 Rectal Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The standard treatment of rectal adenocarcinoma is total mesorectal excision (TME). The technique involves a low anterior rectal or colo-anal resection, very often associated with a protective stoma or abdominal-perineal resection with permanent colostomy. Transanal endoscopic microsurgery (TEM) allows access to tumors up to 20 cm from the anal margin, with minimal postoperative morbidity and mortality. Recent studies of T1 rectal adenocarcinomas consider TEM to be the technique of choice. However the treatment of T2 rectal cancers remains controversial. Chemotherapy and radiotherapy (CT/RT) has achieved a concomitant reduction in local recurrence and an increase in survival. Hypothesis: Patients with rectal adenocarcinoma less than 10 cm from the anal margin and up to 4 cm in size, staged after endorectal ultrasound and MRI as T2 or superficial T3 N0-M0-N0-M0, who underwent surgery after preoperative local chemoradiotherapy (TEM), achieve effective results in terms of local recurrence similar to radical surgery (TME). OBJECTIVES: Primary: To compare the results of local recurrence at 2 years in patients treated with preoperative chemoradiotherapy and TEM and in patients treated with conventional radical surgery (TME). Secondary: To analyse the 3-year survival results in patients treated with CT/RT. Methodology: Multicenter clinical trial in a calculated sample of 173 patients.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine (Xeloda)	Capecitabine 825 mg/m2 every 12 hours orally on days of radiotherapy
RADIATION	50.4 Gy	Radiotherapy was administered in daily fractions of 1.8 Gy 5 days a week according to standard schema. The total dose is 45 Gy plus a boost of 5.4 Gy to the tumor area
PROCEDURE	Transanal Endoscopic Microsurgery	6-8 weeks after Chemoradiotherapy
PROCEDURE	Total Mesorectal Excision	Standard surgical treatment of T2 , T3s, N0, M0 rectal cancer. Early after diagnosis

Timeline

• Start date: 2010-08-01
• Primary completion: 2017-12-01
• Completion: 2021-10-01
• First posted: 2011-03-04
• Last updated: 2021-11-23

Locations

1 site across 1 country: Spain