We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer (TiMiSNAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03465982
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
Igor Monsellato, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and thirty-two patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks. The recruiting interval will be of 5 years and the follow-up period will end 5 years after the last patient is randomized.

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: Surgery after 8 weeks from chemoradiation treatment Procedure: Surgery after 12 weeks from chemoradiation treatment Not Applicable

Detailed Description:

PURPOSE

To demonstrate if delayed timing of surgery after neoadjuvant chemoradiotherapy actually affects pathological complete response (pCR) and reflects on disease-free survival (DFS) and overall survival (OS) rather than standard timing. Eight weeks are the current standard interval to surgery after neoadjuvant treatment, while 12 weeks represent the "minimum" longer time interval to determine further tumor modifications and the "a priori" choice to avoid hypothetical surgical detrimental effect (postoperative complications related to radiation therapy).

Primary Endpoint

  • pCR

Secondary Endpoints

  • DFS
  • OS
  • QoL (quality of Life)

Site Eligibility

The trial is a multicenter collaboration, involving all those centers able to provide the standard of cure for locally advanced rectal cancer. All the involved centers have to respect the following criteria:

  • Site able to perform robotic-assisted and standard laparoscopic rectal cancer surgery and TaTME (transanal total mesorectal excision)
  • Site able to provide a preoperative work up according to the work up criteria specified in this trial
  • Site able to provide standard neoadjuvant treatment, both chemo and radiation therapy, according to the criteria specified in this trial
  • Predicted capability to recruit a minimum of 15 patients per year to the trial.

Randomization will take place after consent is obtained and after patients have completed their baseline patient reported questionnaires. Patient consent and randomization will take place as close to the date of start of the neoadjuvant treatment as possible and must be no more than 30 days prior to planned treatment.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer: a Multicenter Randomised Controlled Trial
Actual Study Start Date : June 5, 2018
Estimated Primary Completion Date : June 5, 2024
Estimated Study Completion Date : June 5, 2029
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Standard Interval Time Arm
Minimally invasive surgery after 8 weeks from chemoradiation treatment
 Procedure: Surgery after 8 weeks from chemoradiation treatment
Minimally invasive surgery after 8 weeks from chemoradiation treatment
Active Comparator: Delayed Interval Time Arm
Minimally invasive surgery after 12 weeks from chemoradiation treatment
 Procedure: Surgery after 12 weeks from chemoradiation treatment
Minimally invasive surgery after 12 weeks from chemoradiation treatment


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. pathologic complete response (pCR) [ Time Frame: 8-12 weeks ]
    Pathologic Complete response on cancer defined as absence of cancer cells on specimen


Secondary Outcome Measures :
  1. DFS [ Time Frame: 5 years ]
    Disease Free survival

  2. OS [ Time Frame: 5 years ]
    Overall Survival


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years
  • cT3/4N0/+M0 confirmed on CT-scan, MRI (stratification for T3a-b-c-d) 3
  • Tumor starting from the distal or medium rectum (even those crossing the peritoneal reflection at distal margin, within 15 cm from the anal margin)
  • Histologically-proven adenocarcinoma of the rectum
  • Eligible for a resective surgery with TME (low anterior resection, intersphincteric resection, abdominoperineal resection)
  • Eligible for resection by minimally-invasive surgery (standard or robotic-assisted laparoscopic procedure, all robotic systems will be accepted)
  • Eligible for chemoradiation treatment
  • Able to give written informed consent
  • Capable of completing required questionnaires at time of consent (provided questionnaires are available in a language spoke fluently by the participant)

Exclusion Criteria:

  • Metastatic disease
  • Squamous carcinoma of the anal canal
  • Synchronous colorectal tumors requiring multi-segment surgical resection (n.b. a benign lesion within the resection field in addition to the main cancer would not exclude a patient)
  • History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
  • Pregnancy
  • Unable to complete neoadjuvant treatment
  • Unable to give free informed consent
  • Previous radiation treatment on the pelvis
  • Inflammatory bowel disease
  • Hereditary colorectal disease
  • Previous tumors other than non-melanoma skin cancer, papillary or follicular thyroid cancer
  • Participation in another rectal cancer clinical trial relating to the topic of this trial
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465982


Contacts
Layout table for location contacts
Contact: Igor Monsellato, MD +390131206506 igor.monsellato@ospedale.al.it

Locations
Layout table for location information
Italy
SS. Antonio e Biagio e Cesare Arrigo Hospital Recruiting
Alessandria, AL, Italy, 15121
Contact: Igor Monsellato, Md, PhD         
Principal Investigator: Igor Monsellato, MD, PhD         
Sub-Investigator: Fabio Priora, MD         
Ospedale Gian Battista Morgagni - Luigi Pierantoni Recruiting
Forlì, Forlì-Cesena, Italy
Contact: Davide Cavaliere, MD         
Principal Investigator: Davide Cavaliere, MD         
Ospedale Civile Pietro Cosma Recruiting
Camposampiero, Padua, Italy
Contact: Enzo Mammano, MD         
Principal Investigator: Emilio Morpurgo, MD         
Sub-Investigator: Tania Contardo, MD         
Ospedale Sacro Cuore Recruiting
Negrar, Verona, Italy
Contact: Giacomo Ruffo         
Principal Investigator: Giacomo Ruffo, MD         
Sub-Investigator: Filippo Alongi, Prof         
Ente Ecclesiastico ospedale generale Regionale Miulli Recruiting
Acquaviva Delle Fonti, Italy
Contact: Alessia Surgo         
Principal Investigator: Alessia Surgo         
Sub-Investigator: Alba Fiorentino         
Ospedale degli Infermi Recruiting
Biella, Italy
Contact: Roberto Perinotti, MD         
Principal Investigator: Roberto Perinotti, MD         
Sub-Investigator: Roberto Polastri, MD         
Azienda Ospedaliera Universitaria Careggi Recruiting
Firenze, Italy
Contact: Federico Perna, MD         
Principal Investigator: Federico Perna, MD         
Sub-Investigator: Benedetta Menegatti, MD         
Sub-Investigator: Andrea Coratti, Prof         
Ospedale Maggiore Policlinico Fondazione Ca' Granda Recruiting
Milano, Italy
Contact: Luigi Boni, FACS         
Principal Investigator: Luigi Boni, FACS         
Sub-Investigator: Elisa Cassinotti, MD         
Ospedale San Raffaele IRCCS Recruiting
Milano, Italy
Contact: Ugo Elmore         
Principal Investigator: Ugo Elmore         
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale Recruiting
Napoli, Italy
Contact: Paolo Delrio, Prof         
Principal Investigator: Paolo Delrio, Prof         
Sub-Investigator: Daniela Rega, MD         
Ospedale San Francesco Recruiting
Nuoro, Italy
Contact: Fabio Pulighe, MD         
Sub-Investigator: Carlo De Nisco, MD         
Principal Investigator: Fabio Pulighe, MD         
Ospedale Sant' Antonio Recruiting
Padova, Italy
Contact: Enzo Mammano         
Principal Investigator: Emilio Morpurgo         
Sub-Investigator: Enzo Mammano         
Azienda Ospedaliera San Giovanni - Addolorata Recruiting
Roma, Italy
Contact: Graziano Pernazza, MD         
Principal Investigator: Graziano Pernazza, MD         
Sponsors and Collaborators
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
  Study Documents (Full-Text)

Documents provided by Igor Monsellato, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria:
Study Protocol and Statistical Analysis Plan  [PDF] November 28, 2018

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Igor Monsellato, Principal Investigator, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
ClinicalTrials.gov Identifier: NCT03465982    
Other Study ID Numbers: 1/18
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Igor Monsellato, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria:
rectal cancer
robotic rectal cancer resection
minimally invasive surgery
Colorectal Cancer
chemoradiation treatment rectal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases