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Neoadjuvant Radiotherapy Followed by Transanal Endoscopic Microsurgery for T1-T2 Extraperitoneal Rectal Cancer

NCT02127645 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-07-26

No results posted yet for this study

Summary

Objective: Recent randomized and non-randomized studies suggest that neoadjuvant radiotherapy followed by Transanal Endoscopic Microsurgery (TEM) show comparative results to abdominal resection in pT2 extraperitoneal cancer. As the risk of lymphnode metastases is significant already for T1 invasive cancers with submucosa infiltration \>1 mm it is our intention to investigate in both T1sm2-3 and T2 rectal adenocarcinomas the effectiveness of this combined treatment in a case series comparing results of this pilot study to an historical series of patients affected by T1-T2 rectal cancer who underwent anterior resection (AR) or total mesorectal excision (TME) with or without abdomino-perineal resection (APR) with no neoadjuvant therapy.

If equally effective, TEM offers a further reduction in invasiveness of treatment, which should correspond to a lower morbidity, mortality and a better quality of life.

Conditions

Interventions

PROCEDURE

SRT-TEM

SRT-TEM underwent 25 Gy RT followed by TEM

PROCEDURE

LRT-TEM

TEM following 46 Gy RT

PROCEDURE

Transanal Endoscopic Microsurgery (TEM)

Transanal Endoscopic Microsurgery (TEM)

PROCEDURE

Total Mesorectal Excision (TME)

Laparoscopic Total Mesorectal Excision

Sponsors & Collaborators

  • European Association for Endoscopic Surgery

    lead OTHER

Principal Investigators

  • Alberto Arezzo, Assistant Professor of Surgery · European Association of Endoscopic Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02127645 on ClinicalTrials.gov