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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

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


Inclusion Criteria:



1. Rectal adenocarcinomas located 10 cm or less from the inferior anal verge measured
using a rigid rectoscope at the time of the EUS.

2. 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.

3. 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.

4. ASA score III or less.

5. Absence of distance metastasis as shown on abdominal CT.

Exclusion Criteria:

1. Preoperative staging by EUS or pelvic MRI of T1, deep T3, T4 or N1.

2. Presence of distance metastasis.

3. Synchrony with other colorectal adenocarcinomas.

4. Undifferentiated rectal adenocarcinomas or with presence of poor prognosis factors in
preoperative biopsy.

5. Patients with intolerance of preoperative chemotherapy or radiotherapy.

6. Refusal to sign informed consent to enter the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local recurrence

Outcome Description:

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).

Outcome Time Frame:

2 years

Safety Issue:

Yes

Authority:

Spain: Spanish Agency of Medicines

Study ID:

TAU-TEM-2009-01

NCT ID:

NCT01308190

Start Date:

August 2010

Completion Date:

December 2015

Related Keywords:

  • Rectal Cancer
  • Preoperative chemoradiotherapy
  • Transanal endoscopic microsurgery
  • Rectal Cancer
  • T2-T3s-N0
  • Rectal Neoplasms

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