Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer
TiMiSNAR
1 other identifier
interventional
340
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2018
Longer than P75 for not_applicable
14 active sites
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
First Submitted
Initial submission to the registry
February 23, 2018
CompletedFirst Posted
Study publicly available on registry
March 15, 2018
CompletedStudy Start
First participant enrolled
June 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2029
ExpectedApril 16, 2024
April 1, 2024
7 years
February 23, 2018
April 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pathologic complete response (pCR)
Pathologic Complete response on cancer defined as absence of cancer cells on specimen
8-12 weeks
Secondary Outcomes (2)
DFS
5 years
OS
5 years
Study Arms (2)
Standard Interval Time Arm
ACTIVE COMPARATORMinimally invasive surgery after 8 weeks from chemoradiation treatment
Delayed Interval Time Arm
ACTIVE COMPARATORMinimally invasive surgery after 12 weeks from chemoradiation treatment
Interventions
Minimally invasive surgery after 8 weeks from chemoradiation treatment
Minimally invasive surgery after 12 weeks from chemoradiation treatment
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
SS. Antonio e Biagio e Cesare Arrigo Hospital
Alessandria, AL, 15121, Italy
Ospedale Gian Battista Morgagni - Luigi Pierantoni
Forlì, Forlì-Cesena, Italy
Ospedale Civile Pietro Cosma
Camposampiero, Padua, Italy
Ospedale Sacro Cuore
Negrar, Verona, Italy
Ente Ecclesiastico ospedale generale Regionale Miulli
Acquaviva delle Fonti, Italy
Ospedale degli Infermi
Biella, Italy
Istituto del Radio Olindo Alberti, Spedali Civili di Brescia
Brescia, Italy
ASST Ospedale di Cremona
Cremona, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Ospedale Maggiore Policlinico Fondazione Ca' Granda
Milan, Italy
Ospedale San Raffaele IRCCS
Milan, Italy
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale
Napoli, Italy
Ospedale San Francesco
Nuoro, Italy
Azienda Ospedaliera San Giovanni - Addolorata
Roma, Italy
Related Publications (6)
Sauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694.
PMID: 15496622RESULTPetrelli F, Sgroi G, Sarti E, Barni S. Increasing the Interval Between Neoadjuvant Chemoradiotherapy and Surgery in Rectal Cancer: A Meta-analysis of Published Studies. Ann Surg. 2016 Mar;263(3):458-64. doi: 10.1097/SLA.0000000000000368.
PMID: 24263329RESULTErlandsson J, Holm T, Pettersson D, Berglund A, Cedermark B, Radu C, Johansson H, Machado M, Hjern F, Hallbook O, Syk I, Glimelius B, Martling A. Optimal fractionation of preoperative radiotherapy and timing to surgery for rectal cancer (Stockholm III): a multicentre, randomised, non-blinded, phase 3, non-inferiority trial. Lancet Oncol. 2017 Mar;18(3):336-346. doi: 10.1016/S1470-2045(17)30086-4. Epub 2017 Feb 10.
PMID: 28190762RESULTKaytan-Saglam E, Balik E, Saglam S, Akgun Z, Ibis K, Keskin M, Dagoglu N, Kapran Y, Gulluoglu M. Delayed versus immediate surgery following short-course neoadjuvant radiotherapy in resectable (T3N0/N+) rectal cancer. J Cancer Res Clin Oncol. 2017 Aug;143(8):1597-1603. doi: 10.1007/s00432-017-2406-6. Epub 2017 Apr 3.
PMID: 28374169RESULTLefevre JH, Mineur L, Kotti S, Rullier E, Rouanet P, de Chaisemartin C, Meunier B, Mehrdad J, Cotte E, Desrame J, Karoui M, Benoist S, Kirzin S, Berger A, Panis Y, Piessen G, Saudemont A, Prudhomme M, Peschaud F, Dubois A, Loriau J, Tuech JJ, Meurette G, Lupinacci R, Goasgen N, Parc Y, Simon T, Tiret E. Effect of Interval (7 or 11 weeks) Between Neoadjuvant Radiochemotherapy and Surgery on Complete Pathologic Response in Rectal Cancer: A Multicenter, Randomized, Controlled Trial (GRECCAR-6). J Clin Oncol. 2016 Nov 1;34(31):3773-3780. doi: 10.1200/JCO.2016.67.6049.
PMID: 27432930RESULTMonsellato I, Alongi F, Bertocchi E, Gori S, Ruffo G, Cassinotti E, Baldari L, Boni L, Pernazza G, Pulighe F, De Nisco C, Perinotti R, Morpurgo E, Contardo T, Mammano E, Elmore U, Delpini R, Rosati R, Perna F, Coratti A, Menegatti B, Gentilli S, Baroffio P, Buccianti P, Balestri R, Ceccarelli C, Torri V, Cavaliere D, Solaini L, Ercolani G, Traverso E, Fusco V, Rossi M, Priora F, Numico G, Franzone P, Orecchia S. Standard (8 weeks) vs long (12 weeks) timing to minimally-invasive surgery after NeoAdjuvant Chemoradiotherapy for rectal cancer: a multicenter randomized controlled parallel group trial (TiMiSNAR). BMC Cancer. 2019 Dec 16;19(1):1215. doi: 10.1186/s12885-019-6271-3.
PMID: 31842784DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 23, 2018
First Posted
March 15, 2018
Study Start
June 5, 2018
Primary Completion
June 5, 2025
Study Completion (Estimated)
June 5, 2029
Last Updated
April 16, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share