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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 22, 2021
Sponsor:
Information provided by (Responsible Party):
Igor Monsellato, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Tracking Information
First Submitted Date  ICMJE February 23, 2018
First Posted Date  ICMJE March 15, 2018
Last Update Posted Date October 22, 2021
Actual Study Start Date  ICMJE June 5, 2018
Estimated Primary Completion Date June 5, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
pathologic complete response (pCR) [ Time Frame: 8-12 weeks ]
Pathologic Complete response on cancer defined as absence of cancer cells on specimen
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • DFS [ Time Frame: 5 years ]
    Disease Free survival
  • OS [ Time Frame: 5 years ]
    Overall Survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer
Official Title  ICMJE Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer: a Multicenter Randomised Controlled Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Cancer
Intervention  ICMJE
  • Procedure: Surgery after 8 weeks from chemoradiation treatment
    Minimally invasive surgery after 8 weeks from chemoradiation treatment
  • Procedure: Surgery after 12 weeks from chemoradiation treatment
    Minimally invasive surgery after 12 weeks from chemoradiation treatment
Study Arms  ICMJE
  • Active Comparator: Standard Interval Time Arm
    Minimally invasive surgery after 8 weeks from chemoradiation treatment
    Intervention: Procedure: Surgery after 8 weeks from chemoradiation treatment
  • Active Comparator: Delayed Interval Time Arm
    Minimally invasive surgery after 12 weeks from chemoradiation treatment
    Intervention: Procedure: Surgery after 12 weeks from chemoradiation treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 15, 2021)
340
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2018)
332
Estimated Study Completion Date  ICMJE June 5, 2029
Estimated Primary Completion Date June 5, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Igor Monsellato, MD +390131206506 igor.monsellato@ospedale.al.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03465982
Other Study ID Numbers  ICMJE 1/18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Igor Monsellato, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP