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Trial record 27 of 1551 for:    rectal cancer

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

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ClinicalTrials.gov Identifier: NCT03465982
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Igor Monsellato, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 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, 2023
Estimated Study Completion Date : June 5, 2028

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




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



Information from the National Library of Medicine

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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

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
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Contact: Igor Monsellato, MD +390131206506 igor.monsellato@ospedale.al.it

Locations
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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         
Casa Sollievo della Sofferenza Opera Padre Pio Recruiting
San Giovanni Rotondo, Foggia, Italy
Contact: Matteo Scaramuzzi, MD         
Principal Investigator: Matteo Scaramuzzi, MD         
Ospedale Gian Battista Morgagni - Luigi Pierantoni Enrolling by invitation
Forlì, Forlì-Cesena, Italy
Ospedale Civile Pietro Cosma Active, not recruiting
Camposampiero, Padua, Italy
Ospedale Sacro Cuore Recruiting
Negrar, Verona, Italy
Contact: Giacomo Ruffo         
Principal Investigator: Giacomo Ruffo, MD         
Sub-Investigator: Filippo Alongi, Prof         
Ospedale degli Infermi Recruiting
Biella, Italy
Contact: Roberto Perinotti, MD         
Principal Investigator: Roberto Perinotti, MD         
Sub-Investigator: Roberto Polastri, MD         
Azienda Ospedaliera Universitaria Careggi Enrolling by invitation
Firenze, Italy
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         
Azienda Ospedaliero Universitaria Maggiore della Carità Active, not recruiting
Novara, Italy
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 Ospedaliero Universitaria Pisana (AOUP) Enrolling by invitation
Pisa, Italy
Azienda Ospedaliera San Giovanni - Addolorata Active, not recruiting
Roma, Italy
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:

Publications of Results:

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Responsible Party: Igor Monsellato, Principal Investigator, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
ClinicalTrials.gov Identifier: NCT03465982     History of Changes
Other Study ID Numbers: 1/18
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases