Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Total Mesorectal Excision in T2-T3s N0, M0 Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT01308190|
Recruitment Status : Unknown
Verified September 2015 by Xavier Serra-Aracil, Corporacion Parc Tauli.
Recruitment status was: Recruiting
First Posted : March 4, 2011
Last Update Posted : September 10, 2015
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).
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.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Drug: Capecitabine (Xeloda) Radiation: 50.4 Gy Procedure: Transanal Endoscopic Microsurgery Procedure: Total Mesorectal Excision||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||173 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Chemoradiotherapy+TEM
Preoperative chemotherapy: capecitabine 825 mg/m2 every 12 hours orally, plus Radiotherapy (50.4 Gy). After 6-8 weeks, transanal endoscopic microsurgery (TEM)is done
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
Total Mesorectal Excision
Standard surgical treatment of T2 , T3s, N0, M0 rectal cancer
Procedure: Total Mesorectal Excision
Standard surgical treatment of T2 , T3s, N0, M0 rectal cancer. Early after diagnosis
- Local recurrence [ Time Frame: 2 years ]To analyse the results for local recurrence after 2 years in patients treated with preoperative chemoradiotherapy and TEO, with patients treated with conventional radical surgery (TME).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308190
|Contact: Xavier Serra-Aracil, MD||+34937231010 ext email@example.com|
|Corporació Parc Taulí||Recruiting|
|Sabadell, Barcelona, Spain, 08208|
|Contact: Xavier Serra-Aracil, MD +34937231010 ext 2009 firstname.lastname@example.org|
|Principal Investigator: Xavier Serra-Aracil, MD|
|Sub-Investigator: Jordi Bombardo-Juncà, MD|
|Sub-Investigator: Carles Pericay Pijaume, MD|