The Stoma Closure Before or After Adjuvant Therapy Trial (STOMAD)

September 20, 2022 updated by: Paolo Massucco, Ospedale Umberto I di Torino

Multicenter Randomized Controlled Phase III Trial Comparing Ileostomy Closure Before or After Adjuvant Therapy in Patients Operated for Rectal Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Diverting ileostomy is effective in reducing severity of anastomotic complications in rectal low anterior resections and it is therefore widely used especially after neoadjuvant chemoradiation treatment. In current clinical practice, in patients with indication to adjuvant chemotherapy, closure of ileostomy is usually performed after the end of the treatment. However, a prolonged presence of the ostomy can induce the onset of ostomy-related complications such as stoma prolapse, parastomal hernia, mechanical ileus, high flow dehydration and damage to renal function. The ostomy-related complications may require unplanned or prolonged hospitalization, thus increasing costs.

Furthermore, the presence of the stoma may affect quality of life, causing alteration of the body image and imposing changes in the daily routine and lifestyle.

Early closure of the ileostomy in patients without signs of postoperative fistula has therefore been proposed.

Outcomes of early closure (within one month from surgery) of diverting ileostomy were demonstrated to be equal to those of late closure (more than 12 weeks from surgery) in 2 randomized trials. Early closure may favor a better quality of life for patients, shortening the life-period with ileostomy, reduces health system economic expenditure and may represent the most desirable and convenient choice. It was also associated with better long term functional results in a randomized trial.

In patients with indication to adjuvant therapy, however, timing to closure of the ostomy (before the start, during or at the end of treatment) is still a matter of debate in terms of compliance to systemic treatment, quality of life and overall costs.

A recent multicenter retrospective study reported an increase in gastrointestinal toxicity in ostomy patients with a significant reduction in treatment compliance.

On the other hand, early closure of the ostomy could unmask anterior resection syndrome (LARS) before chemotherapy, with potential negative impact on the tolerability of the treatment, or reveal postoperative complications thus delaying chemotherapy treatment.

The trial will investigate which is the best strategy of dealing with temporary ileostomy in relation to adjuvant therapy.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alba, Italy
        • Ospedale S. Lazzaro - Chirurgia Generale (Dott. Calgaro)
      • Aosta, Italy
        • Ospedale Parini - Chirurgia Generale (Dott. Millo)
      • Novara, Italy
        • Ospedale Maggiore della Carità - Chirurgia Generale (Dott. Romito)
      • Novara, Italy
        • Ospedale Maggiore della Carità - Chirurgia Universitaria (Prof. Gentilli)
      • Torino, Italy
        • Ospedale Martini - Chirurgia Generale (Dott. Saracco)
      • Torino, Italy
        • Ospedale Mauriziano - Chirurgia Generale (Dott. Ferrero)
      • Torino, Italy
        • Ospedale Molinette - Chirurgia Generale (Dott. De Paolis)
      • Torino, Italy
        • Ospedale Molinette - Chirurgia Universitaria (Prof. Morino)
    • AL
      • Acqui Terme, AL, Italy
        • Ospedale Mons. Galliano - Chirurgia Generale (Dott. Serventi)
      • Alessandria, AL, Italy
        • Ospedale SS. Antonio e Biagio - Chirurgia Generale (Dott. Priora)
      • Casale Monferrato, AL, Italy
        • Ospedale S. Spirito - Chirurgia Generale (Dott. Amisano)
      • Novi Ligure, AL, Italy
        • Ospedale S. Giacomo - Chirurgia Generale (Dott. Di Somma)
    • AT
      • Asti, AT, Italy
        • Ospedale Cardinal Massaia - Chirurgia Generale (Dott. Sorisio)
    • BI
      • Biella, BI, Italy
        • Ospedale degli Infermi - Chirurgia Generale (Dott. Polastri)
    • CN
      • Cuneo, CN, Italy
        • Ospedale S. Croce e Carle - Chirurgia Generale (Dott. Borghi)
      • Mondovì, CN, Italy
        • Ospedale Regina Montis Regalis - Chirurgia Generale (Dott. Gattolin)
      • Savigliano, CN, Italy
        • Ospedale SS. Annunziata - Chirurgia Generale (Dott. Bertolino)
    • TO
      • Candiolo, TO, Italy
        • IRCCS - Chirurgia Colorettale (Dott. Ribero)
      • Ciriè, TO, Italy
        • Ospedale di Ciriè - Chirurgia Generale (Dott. Personettaz)
      • Ivrea, TO, Italy
        • Ospedale Civile - Chirurgia Generale (Dott. Rosato)
      • Moncalieri, TO, Italy
        • Ospedale S. Croce - Chirurgia Generale (Dott. Cumbo)
      • Orbassano, TO, Italy
        • Ospedale S. Luigi - Chirurgia Universitaria (Prof. Degiuli)
      • Pinerolo, TO, Italy
        • Ospedale Agnelli - Chirurgia Generale (Dott. Muratore)
      • Rivoli, TO, Italy
        • Ospedale degli Infermi - Chirurgia Generale (Dott. Garino)
      • Torino, TO, Italy
        • Ospedale Cottolengo - Chirurgia Generale (Dott. Bima)
      • Torino, TO, Italy
        • Ospedale Humanitas Gradenigo - Chirurgia Generale (Dott. Leli)
    • VB
      • Domodossola, VB, Italy
        • Ospedale S. Biagio - Chirurgia Generale (Dott. Zonta)
    • VC
      • Vercelli, VC, Italy
        • Ospedale S. Andrea - Chirurgia Generale (Dott. Testa)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early stoma closure
Ileostomy closure between 30 and 40 day after rectal resection
Other: Timing of stoma closure
Defining the best timing of stoma closure in relation to adjuvant therapy compliance
Active Comparator: Delayed stoma closure
Ileostomy closure 15 days from the end of adjuvant therapy (up to 60 days)
Other: Timing of stoma closure
Defining the best timing of stoma closure in relation to adjuvant therapy compliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with good compliance to adjuvant therapy
Time Frame: Measured within 48 hours after the end of the last cycle of 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of stoma-related complications
Time Frame: All over the study duration (up to 12 months from randomization)
Adverse events related to the presence of stoma and postoperative complication after stoma closure
All over the study duration (up to 12 months from randomization)
Rate of chemotherapy side effects
Time Frame: Immediately after the end of every single cycle (each cycle duration varies from 5 to 14 days according to the chosen scheme)
According to CTCAE classification
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
Time Frame: 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
Measured by EORTC C30
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
Time Frame: 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
Measured by EORTC CR29
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
Time Frame: 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
Measured by EQ-5D-3L
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
Bowel function
Time Frame: At 12 months from rectal resection
Measured by LARS (Low Anterior Resection Syndrome) score
At 12 months from rectal resection
Overall survival
Time Frame: Ut to 3 years from inclusion of the last patient
From randomization date to death from any cause or date of last contact
Ut to 3 years from inclusion of the last patient
Progression free survival
Time Frame: Ut to 3 years from inclusion of the last patient
From randomization date to progression diagnosis or date of last contact
Ut to 3 years from inclusion of the last patient
Costs analysis
Time Frame: At 12 months from randomization
Mean cumulative costs in euro of the postoperative phase including outpatient visits, hospital stay for stoma closure, hospital re-entry and expenditures for stoma care appliances based on life-days with the stoma. Excluded are costs related to adjuvant treatment.
At 12 months from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Umberto I di Torino

Collaborators

Rete Oncologica Piemonte, Valle d'Aosta

Investigators

  • Principal Investigator: Paolo Massucco, MD, OA Ordine Mauriziano - Torino, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROPCR01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymized IPD will be available for 36 months after the results publication upon request to the principal investigator. Data will be provided in an electronic dataset containing deidentified participant files by the Unit of Epidemiology of the Azienda Ospedaliera Universitaria Città della Salute e della Scienza, Turin (Italy) after evaluation and approval of the request by the trial steering committee.

IPD Sharing Time Frame

For 36 months after trial results publication

IPD Sharing Access Criteria

Address data sharing request to the principal investigator. All requests will be evaluated and must be approved by the trial steering committee.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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