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

April 15, 2024 updated by: Igor Monsellato, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer: a Multicenter Randomised Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
340

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Acquaviva Delle Fonti, Italy
        • Suspended
        • Ente Ecclesiastico Ospedale Generale Regionale Miulli
      • Biella, Italy
        • Recruiting
        • Ospedale degli Infermi
        • Contact:
          • Roberto Perinotti, MD
        • Principal Investigator:
          • Roberto Perinotti, MD
        • Sub-Investigator:
          • Roberto Polastri, MD
      • Brescia, Italy
        • Recruiting
        • Istituto del Radio Olindo Alberti, Spedali Civili di Brescia
        • Contact:
        • Sub-Investigator:
          • Vittorio Morelli, MD
      • Cremona, Italy
      • Firenze, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi
        • Contact:
          • Federico Perna, MD
        • Principal Investigator:
          • Federico Perna, MD
        • Sub-Investigator:
          • Benedetta Menegatti, MD
        • Sub-Investigator:
          • Andrea Coratti, Prof
      • Milano, Italy
        • Recruiting
        • Ospedale Maggiore Policlinico Fondazione Ca' Granda
        • Contact:
          • Luigi Boni, FACS
        • Principal Investigator:
          • Luigi Boni, FACS
        • Sub-Investigator:
          • Elisa Cassinotti, MD
      • Milano, Italy
        • Recruiting
        • Ospedale San Raffaele IRCCS
        • Contact:
          • Ugo Elmore
        • Principal Investigator:
          • Ugo Elmore
      • Napoli, Italy
        • Recruiting
        • Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale
        • Contact:
          • Paolo Delrio, Prof
        • Principal Investigator:
          • Paolo Delrio, Prof
        • Sub-Investigator:
          • Daniela Rega, MD
      • Nuoro, Italy
        • Terminated
        • Ospedale San Francesco
      • Roma, Italy
        • Suspended
        • Azienda Ospedaliera San Giovanni - Addolorata
    • AL
      • Alessandria, AL, Italy, 15121
        • Recruiting
        • SS. Antonio e Biagio e Cesare Arrigo Hospital
        • Contact:
          • Igor Monsellato, Md, PhD
        • Principal Investigator:
          • Igor Monsellato, MD, PhD
        • Sub-Investigator:
          • Fabio Priora, MD
    • Forlì-Cesena
      • Forlì, Forlì-Cesena, Italy
        • Recruiting
        • Ospedale Gian Battista Morgagni - Luigi Pierantoni
        • Contact:
          • Davide Cavaliere, MD
        • Principal Investigator:
          • Davide Cavaliere, MD
    • Padua
      • Camposampiero, Padua, Italy
        • Recruiting
        • Ospedale Civile Pietro Cosma
        • Contact:
          • Enzo Mammano, MD
        • Principal Investigator:
          • Emilio Morpurgo, MD
        • Sub-Investigator:
          • Tania Contardo, MD
    • Verona
      • Negrar, Verona, Italy
        • Recruiting
        • Ospedale Sacro Cuore
        • Principal Investigator:
          • Giacomo Ruffo, MD
        • Contact:
          • Giacomo Ruffo
        • Sub-Investigator:
          • Filippo Alongi, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pathologic complete response (pCR)
Time Frame: 8-12 weeks
Pathologic Complete response on cancer defined as absence of cancer cells on specimen
8-12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DFS
Time Frame: 5 years
Disease Free survival
5 years
OS
Time Frame: 5 years
Overall Survival
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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