The Stoma Closure Before or After Adjuvant Therapy Trial

NCT04372992 | Terminated DMC

• 1 other identifier: ROPCR01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 28

Brief Summary

This is an open-label multicenter controlled trial, including 28 centers from the Rete Oncologica (Oncological Network) of Piemonte and Valle d'Aosta in Italy (http://www.reteoncologica.it). After a curative resection for rectal cancer and temporary ileostomy, 270 patients with indication to adjuvant chemotherapy will be randomized to early (before starting adjuvant treatment) or late (after adjuvant treatment completion) stoma closure. Primary end point will the compliance to adjuvant therapy. Secondary endpoint will include quality of life and bowel function evaluation, postoperative morbidity, chemotherapy toxicity, oncological outcomes and costs comparison.

Conditions

Ileostomy; Rectal Cancer

Keywords

Chemotherapy, Adjuvant; Early closure; Late closure

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with good compliance to adjuvant therapy

  Composite outcome measure including timeliness and percentage of planned dose received. In each subject, treatment compliance is defined as good if both the following conditions are met: 1. adjuvant therapy starting date within 10 weeks of rectal resection; 2. total cumulative received dose (mg/m2) \>=70% of planned. The percentage of participants with good compliance in both arms will be compared.

  Measured within 48 hours after the end of the last cycle of adjuvant therapy

Secondary Outcomes (9)

• Rate of stoma-related complications

  All over the study duration (up to 12 months from randomization)

• Rate of chemotherapy side effects

  Immediately after the end of every single cycle (each cycle duration varies from 5 to 14 days according to the chosen scheme)

• Quality of life 1

  At baseline, at the end of cycle 3 (regardless of the cycle duration, that varies from 5 to 14 day according to local investigators choice) and at 12 months from randomization

• Quality of life 2

  At baseline, at the end of cycle 3 (regardless of the cycle duration, that varies from 5 to 14 day according to local investigators choice) and at 12 months from randomization

• Quality of life 3

  At baseline, at the end of cycle 3 (regardless of the cycle duration, that varies from 5 to 14 day according to local investigators choice) and at 12 months from randomization

Study Arms (2)

Early stoma closure

EXPERIMENTAL

Ileostomy closure between 30 and 40 day after rectal resection

Other: Timing of stoma closure

Delayed stoma closure

ACTIVE COMPARATOR

Ileostomy closure 15 days from the end of adjuvant therapy (up to 60 days)

Other: Timing of stoma closure

Interventions

Timing of stoma closure OTHER

Defining the best timing of stoma closure in relation to adjuvant therapy compliance

Delayed stoma closure; Early stoma closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient treated with a curative resection for rectal cancer
• Presence of a temporary ileostomy
• Age \>= 18 years
• Indication to adjuvant treatment
• Absence of anastomotic dehiscence (as proved by enema and/or endoscopy)
• Able to give written informed consent

You may not qualify if:

• ASA \>3
• ECOG Performance Status \>=2
• UICC stage IV
• Severe and non-controlled systemic, oncologic, or infectious disease

Sponsors & Collaborators

• Ospedale Umberto I di Torino: lead
• Rete Oncologica Piemonte, Valle d'Aosta: collaborator

Study Sites (28)

Ospedale Mons. Galliano - Chirurgia Generale (Dott. Serventi)

Acqui Terme, AL, Italy

Location

Ospedale SS. Antonio e Biagio - Chirurgia Generale (Dott. Priora)

Alessandria, AL, Italy

Location

Ospedale S. Spirito - Chirurgia Generale (Dott. Amisano)

Casale Monferrato, AL, Italy

Location

Ospedale S. Giacomo - Chirurgia Generale (Dott. Di Somma)

Novi Ligure, AL, Italy

Location

Ospedale Cardinal Massaia - Chirurgia Generale (Dott. Sorisio)

Asti, AT, Italy

Location

Ospedale degli Infermi - Chirurgia Generale (Dott. Polastri)

Biella, BI, Italy

Location

Ospedale S. Croce e Carle - Chirurgia Generale (Dott. Borghi)

Cuneo, CN, Italy

Location

Ospedale Regina Montis Regalis - Chirurgia Generale (Dott. Gattolin)

Mondovì, CN, Italy

Location

Ospedale SS. Annunziata - Chirurgia Generale (Dott. Bertolino)

Savigliano, CN, Italy

Location

IRCCS - Chirurgia Colorettale (Dott. Ribero)

Candiolo, TO, Italy

Location

Ospedale di Ciriè - Chirurgia Generale (Dott. Personettaz)

Cirié, TO, Italy

Location

Ospedale Civile - Chirurgia Generale (Dott. Rosato)

Ivrea, TO, Italy

Location

Ospedale S. Croce - Chirurgia Generale (Dott. Cumbo)

Moncalieri, TO, Italy

Location

Ospedale S. Luigi - Chirurgia Universitaria (Prof. Degiuli)

Orbassano, TO, Italy

Location

Ospedale Agnelli - Chirurgia Generale (Dott. Muratore)

Pinerolo, TO, Italy

Location

Ospedale degli Infermi - Chirurgia Generale (Dott. Garino)

Rivoli, TO, Italy

Location

Ospedale Cottolengo - Chirurgia Generale (Dott. Bima)

Torino, TO, Italy

Location

Ospedale Humanitas Gradenigo - Chirurgia Generale (Dott. Leli)

Torino, TO, Italy

Location

Ospedale S. Biagio - Chirurgia Generale (Dott. Zonta)

Domodossola, VB, Italy

Location

Ospedale S. Andrea - Chirurgia Generale (Dott. Testa)

Vercelli, VC, Italy

Location

Ospedale S. Lazzaro - Chirurgia Generale (Dott. Calgaro)

Alba, Italy

Location

Ospedale Parini - Chirurgia Generale (Dott. Millo)

Aosta, Italy

Location

Ospedale Maggiore della Carità - Chirurgia Generale (Dott. Romito)

Novara, Italy

Location

Ospedale Maggiore della Carità - Chirurgia Universitaria (Prof. Gentilli)

Novara, Italy

Location

Ospedale Martini - Chirurgia Generale (Dott. Saracco)

Torino, Italy

Location

Ospedale Mauriziano - Chirurgia Generale (Dott. Ferrero)

Torino, Italy

Location

Ospedale Molinette - Chirurgia Generale (Dott. De Paolis)

Torino, Italy

Location

Ospedale Molinette - Chirurgia Universitaria (Prof. Morino)

Torino, Italy

Location

Related Publications (15)

• Montedori A, Cirocchi R, Farinella E, Sciannameo F, Abraha I. Covering ileo- or colostomy in anterior resection for rectal carcinoma. Cochrane Database Syst Rev. 2010 May 12;2010(5):CD006878. doi: 10.1002/14651858.CD006878.pub2.

  PMID: 20464746 BACKGROUND

• Malik T, Lee MJ, Harikrishnan AB. The incidence of stoma related morbidity - a systematic review of randomised controlled trials. Ann R Coll Surg Engl. 2018 Sep;100(7):501-508. doi: 10.1308/rcsann.2018.0126. Epub 2018 Aug 16.

  PMID: 30112948 BACKGROUND

• Brown H, Randle J. Living with a stoma: a review of the literature. J Clin Nurs. 2005 Jan;14(1):74-81. doi: 10.1111/j.1365-2702.2004.00945.x.

  PMID: 15656851 BACKGROUND

• Herrle F, Sandra-Petrescu F, Weiss C, Post S, Runkel N, Kienle P. Quality of Life and Timing of Stoma Closure in Patients With Rectal Cancer Undergoing Low Anterior Resection With Diverting Stoma: A Multicenter Longitudinal Observational Study. Dis Colon Rectum. 2016 Apr;59(4):281-90. doi: 10.1097/DCR.0000000000000545.

  PMID: 26953986 BACKGROUND

• Alves A, Panis Y, Lelong B, Dousset B, Benoist S, Vicaut E. Randomized clinical trial of early versus delayed temporary stoma closure after proctectomy. Br J Surg. 2008 Jun;95(6):693-8. doi: 10.1002/bjs.6212.

  PMID: 18446781 BACKGROUND

• Danielsen AK, Park J, Jansen JE, Bock D, Skullman S, Wedin A, Marinez AC, Haglind E, Angenete E, Rosenberg J. Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial. Ann Surg. 2017 Feb;265(2):284-290. doi: 10.1097/SLA.0000000000001829.

  PMID: 27322187 BACKGROUND

• Park J, Angenete E, Bock D, Correa-Marinez A, Danielsen AK, Gehrman J, Haglind E, Jansen JE, Skullman S, Wedin A, Rosenberg J. Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial). Surg Endosc. 2020 Jan;34(1):69-76. doi: 10.1007/s00464-019-06732-y. Epub 2019 Mar 25.

  PMID: 30911920 BACKGROUND

• Keane C, Park J, Oberg S, Wedin A, Bock D, O'Grady G, Bissett I, Rosenberg J, Angenete E. Functional outcomes from a randomized trial of early closure of temporary ileostomy after rectal excision for cancer. Br J Surg. 2019 Apr;106(5):645-652. doi: 10.1002/bjs.11092. Epub 2019 Feb 1.

  PMID: 30706439 BACKGROUND

• Tulchinsky H, Shacham-Shmueli E, Klausner JM, Inbar M, Geva R. Should a loop ileostomy closure in rectal cancer patients be done during or after adjuvant chemotherapy? J Surg Oncol. 2014 Mar;109(3):266-9. doi: 10.1002/jso.23493. Epub 2013 Nov 19.

  PMID: 24249401 BACKGROUND

• Robertson JP, Wells CI, Vather R, Bissett IP. Effect of Diversion Ileostomy on the Occurrence and Consequences of Chemotherapy-Induced Diarrhea. Dis Colon Rectum. 2016 Mar;59(3):194-200. doi: 10.1097/DCR.0000000000000531.

  PMID: 26855393 BACKGROUND

• Siassi M, Hohenberger W, Losel F, Weiss M. Quality of life and patient's expectations after closure of a temporary stoma. Int J Colorectal Dis. 2008 Dec;23(12):1207-12. doi: 10.1007/s00384-008-0549-2. Epub 2008 Aug 7.

  PMID: 18685854 BACKGROUND

• Chow A, Tilney HS, Paraskeva P, Jeyarajah S, Zacharakis E, Purkayastha S. The morbidity surrounding reversal of defunctioning ileostomies: a systematic review of 48 studies including 6,107 cases. Int J Colorectal Dis. 2009 Jun;24(6):711-23. doi: 10.1007/s00384-009-0660-z. Epub 2009 Feb 17.

  PMID: 19221766 BACKGROUND

• Hofheinz RD, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT, Muller L, Link H, Moehler M, Kettner E, Fritz E, Hieber U, Lindemann HW, Grunewald M, Kremers S, Constantin C, Hipp M, Hartung G, Gencer D, Kienle P, Burkholder I, Hochhaus A. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol. 2012 Jun;13(6):579-88. doi: 10.1016/S1470-2045(12)70116-X. Epub 2012 Apr 13.

  PMID: 22503032 BACKGROUND

• Glynne-Jones R, Counsell N, Quirke P, Mortensen N, Maraveyas A, Meadows HM, Ledermann J, Sebag-Montefiore D. Chronicle: results of a randomised phase III trial in locally advanced rectal cancer after neoadjuvant chemoradiation randomising postoperative adjuvant capecitabine plus oxaliplatin (XELOX) versus control. Ann Oncol. 2014 Jul;25(7):1356-1362. doi: 10.1093/annonc/mdu147. Epub 2014 Apr 8.

  PMID: 24718885 BACKGROUND

• Massucco P, Fontana A, Mineccia M, Perotti S, Ciccone G, Galassi C, Giuffrida MC, Marino D, Monsellato I, Paris MK, Perinotti R, Racca P, Monagheddu C, Saccona F, Ponte E, Mistrangelo M, Santarelli M, Tomaselli F, Reddavid R, Birolo S, Calabro M, Pipitone N, Panier Suffat L, Carrera M, Potente F, Brunetti M, Rimonda R, Adamo V, Piscioneri D, Cravero F, Serventi A, Giaminardi E, Mazza L, Bellora P, Colli F, De Rosa C, Battafarano F, Trapani R, Mellano A, Gibin E, Bellomo P. Prospective, randomised, multicentre, open-label trial, designed to evaluate the best timing of closure of the temporary ileostomy (early versus late) in patients who underwent rectal cancer resection and with indication for adjuvant chemotherapy: the STOMAD (STOMa closure before or after ADjuvant therapy) randomised controlled trial. BMJ Open. 2021 Feb 19;11(2):e044692. doi: 10.1136/bmjopen-2020-044692.

  PMID: 33608405 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Paolo Massucco, MD

  OA Ordine Mauriziano - Torino, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Multicenter controlled trial

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: May 4, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For 36 months after trial results publication
• Access Criteria: Address data sharing request to the principal investigator. All requests will be evaluated and must be approved by the trial steering committee.

Locations

IT (28)