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

Sponsor

Corporacion Parc Tauli (Other)

Overall Status

Completed

CT.gov ID

NCT01308190

Collaborator

Fundación Olga Torres (Other)

173

Enrollment

Location

Arms

134

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

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 Design

Study Type:

Interventional

Actual Enrollment :

173 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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
Other: 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

Arm

Intervention/Treatment

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

Other: 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

Outcome Measures

Primary Outcome Measures

Local recurrence [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Rectal adenocarcinomas located 10 cm or less from the inferior anal verge measured using a rigid rectoscope at the time of the EUS.
Preoperative staging by EUS and pelvic MRI of T2 or T3 superficial, N0. In case of disparity, the higher staging is considered as the definitive diagnosis.
Tumours equal to or less than 4 cm of diameter maximum measured using colonoscopy, EUS or MRI. We use the highest score on both scores.
ASA score III or less.
Absence of distance metastasis as shown on abdominal CT.

Exclusion Criteria:

Preoperative staging by EUS or pelvic MRI of T1, deep T3, T4 or N1.
Presence of distance metastasis.
Synchrony with other colorectal adenocarcinomas.
Undifferentiated rectal adenocarcinomas or with presence of poor prognosis factors in preoperative biopsy.
Patients with intolerance of preoperative chemotherapy or radiotherapy.
Refusal to sign informed consent to enter the study.