Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer
NCT ID: NCT03465982
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
340 participants
INTERVENTIONAL
2018-06-05
2029-06-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Interval Time Arm
Minimally invasive surgery after 8 weeks from chemoradiation treatment
Surgery after 8 weeks from chemoradiation treatment
Minimally invasive surgery after 8 weeks from chemoradiation treatment
Delayed Interval Time Arm
Minimally invasive surgery after 12 weeks from chemoradiation treatment
Surgery after 12 weeks from chemoradiation treatment
Minimally invasive surgery after 12 weeks from chemoradiation treatment
Interventions
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Surgery after 8 weeks from chemoradiation treatment
Minimally invasive surgery after 8 weeks from chemoradiation treatment
Surgery after 12 weeks from chemoradiation treatment
Minimally invasive surgery after 12 weeks from chemoradiation treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
OTHER
Responsible Party
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Igor Monsellato
Principal Investigator
Locations
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SS. Antonio e Biagio e Cesare Arrigo Hospital
Alessandria, AL, 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
Countries
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Central Contacts
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Facility Contacts
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Igor Monsellato, Md, PhD
Role: primary
Davide Cavaliere, MD
Role: primary
Enzo Mammano, MD
Role: primary
Giacomo Ruffo
Role: primary
Roberto Perinotti, MD
Role: primary
Federico Perna, MD
Role: primary
Luigi Boni, FACS
Role: primary
Ugo Elmore
Role: primary
Paolo Delrio, Prof
Role: primary
References
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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.
Petrelli 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.
Erlandsson 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.
Kaytan-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.
Lefevre 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.
Monsellato 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1/18
Identifier Type: -
Identifier Source: org_study_id
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