Please select the arm or intervention descriptions that belong to the clinical trial below.
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
Brief 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.


Options:
A: Arm Label: Total Mesorectal Excision; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Additional TME surgery | Arm Label: Adjuvant chemoradiotherapy; Type: EXPERIMENTAL; Interventions: Radiation: Adjuvant chemoradiotherapy, Drug: capecitabine | Intervention Type: RADIATION; Name: Adjuvant chemoradiotherapy; Assigned to Arm(s): Adjuvant chemoradiotherapy | Intervention Type: PROCEDURE; Name: Additional TME surgery; Assigned to Arm(s): Total Mesorectal Excision | Intervention Type: DRUG; Name: capecitabine; Assigned to Arm(s): Adjuvant chemoradiotherapy
B: Arm Label: Standard TME surgery; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Standard TME surgery | Arm Label: Long course concurrent chemoradiation; Type: EXPERIMENTAL; Interventions: Drug: Long course concurrent chemoradiation with capecitabine and radiotherapy | Arm Label: Short course radiotherapy; Type: EXPERIMENTAL; Interventions: Radiation: Short course radiotherapy | Intervention Type: PROCEDURE; Name: Standard TME surgery; Assigned to Arm(s): Standard TME surgery | Intervention Type: DRUG; Name: Long course concurrent chemoradiation with capecitabine and radiotherapy; Assigned to Arm(s): Long course concurrent chemoradiation | Intervention Type: RADIATION; Name: Short course radiotherapy; Assigned to Arm(s): Short course radiotherapy
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Procedure: local rectal excision | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: total mesorectal excision | Intervention Type: PROCEDURE; Name: local rectal excision; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: total mesorectal excision; Assigned to Arm(s): 2
D: Arm Label: Chemoradiotherapy+TEM; Type: ACTIVE_COMPARATOR; Interventions: Drug: Capecitabine (Xeloda), Radiation: 50.4 Gy, Procedure: Transanal Endoscopic Microsurgery | Arm Label: Total Mesorectal Excision; Type: OTHER; Interventions: Procedure: Total Mesorectal Excision | Intervention Type: DRUG; Name: Capecitabine (Xeloda); Assigned to Arm(s): Chemoradiotherapy+TEM | Intervention Type: RADIATION; Name: 50.4 Gy; Assigned to Arm(s): Chemoradiotherapy+TEM | Intervention Type: PROCEDURE; Name: Transanal Endoscopic Microsurgery; Assigned to Arm(s): Chemoradiotherapy+TEM | Intervention Type: PROCEDURE; Name: Total Mesorectal Excision; Assigned to Arm(s): Total Mesorectal Excision

Answer: D