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

PHASE3CompletedINTERVENTIONAL
Enrollment

173

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

December 31, 2017

Study Completion Date

October 31, 2021

Conditions
Rectal Cancer
Interventions
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

Trial Locations (1)

08208

Corporació Parc Taulí, Sabadell

Sponsors
All Listed Sponsors
collaborator

Fundación Olga Torres

UNKNOWN

lead

Corporacion Parc Tauli

OTHER