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The Stoma Closure Before or After Adjuvant Therapy Trial

NCT04372992 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-09-22

No results posted yet for this study

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

Interventions

OTHER

Timing of stoma closure

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

Sponsors & Collaborators

  • Rete Oncologica Piemonte, Valle d'Aosta

    collaborator OTHER

  • Ospedale Umberto I di Torino

    lead OTHER

Principal Investigators

  • Paolo Massucco, MD · OA Ordine Mauriziano - Torino, Italy

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-09-01
Completion
2022-09-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04372992 on ClinicalTrials.gov