NCT02127645

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

2.9 years

First QC Date

April 26, 2014

Last Update Submit

July 24, 2018

Conditions

RECTAL CANCER

Keywords

RADIOTHERAPYTRANSANAL ENDOSCOPIC MICROSURGERYLOCAL EXCISION

Outcome Measures

Primary Outcomes (1)

  • incidence of local and distant recurrence

    36 months

Secondary Outcomes (3)

  • morbidity, subdivided into major (requiring surgery) and minor (requiring endoscopic or medical intervention)

    30 days

  • disease specific and general quality of life

    30 days

  • anorectal function

    3 months

Study Arms (1)

Early Rectal Cancer

EXPERIMENTAL

patients with T1 - T2, N0, G1-2 rectal cancer

Procedure: SRT-TEMProcedure: LRT-TEMProcedure: Transanal Endoscopic Microsurgery (TEM)Procedure: Total Mesorectal Excision (TME)

Interventions

SRT-TEMPROCEDURE

SRT-TEM underwent 25 Gy RT followed by TEM

Also known as: Transanal Endoscopic Microsurgery (TEM), Neoadjuvant Short course Radio-Therapy
Early Rectal Cancer
LRT-TEMPROCEDURE

TEM following 46 Gy RT

Also known as: Transanal Endoscopic Microsurgery (TEM), Neoadjuvant Long Term Radio-therapy 46 Gy
Early Rectal Cancer
Transanal Endoscopic Microsurgery (TEM)PROCEDURE

Transanal Endoscopic Microsurgery (TEM)

Early Rectal Cancer
Total Mesorectal Excision (TME)PROCEDURE

Laparoscopic Total Mesorectal Excision

Also known as: Laparoscopic Total Mesorectal Excision
Early Rectal Cancer

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with a large rectal sessile or flat lesion (type 0-Is, 0-II or 0-III according to the Paris Classification) with the largest diameter of 2 cm or larger11 (estimated by an opened resection snare).
  • lower and upper borders of the rectal neoplasm located between 2 and 12 cm from the anal verge, respectively.
  • Biopsies of the lesion showed neoplastic tissue adenocarcinoma G1-G2 on histopathological evaluation.
  • Endoscopic ultrasonography (EUS) of the rectal lesion confirmed invasion into the submucosal layer (uT1sm) \>1 mm or the muscle layer (uT2) and ruled out the presence of lymph nodes \>1 cm.
  • Pelvic Magnetic Resonance Imaging (MRI) (or Computer Tomography (CT) when MRI was contraindicated) ruled outlymph nodes \>1 cm.
  • ASA (America Society of Anesthesiologists)- status I-III.

You may not qualify if:

  • previous anorectal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgical Sciences, University of Torino

Turin, Piedmont, 10126, Italy

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Transanal Endoscopic Microsurgery

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Transanal Endoscopic SurgeryNatural Orifice Endoscopic SurgeryEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisProctoscopyEndoscopy, GastrointestinalEndoscopy, Digestive SystemDigestive System Surgical ProceduresSurgical Procedures, OperativeMicrosurgeryMinimally Invasive Surgical Procedures

Study Officials

  • Alberto Arezzo, Assistant Professor of Surgery

    European Association of Endoscopic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

April 26, 2014

First Posted

May 1, 2014

Study Start

June 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

IT(1)