Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Ttransanal Endoscopic Microsurgery in T1 N0, M0 Rectal Cancer (TAUTEM-T1 Study)

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2027

Conditions
Rectal Cancer Stage I
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 (TEM)

10 weeks after Chemoradiotherapy

PROCEDURE

Transanal Endoscopic Microsurgery

Standard surgical treatment of T1, N0, M0 rectal cancer. Early after diagnosis

Sponsors
All Listed Sponsors
lead

Corporacion Parc Tauli

OTHER