TerminatedNot Applicable

The Stoma Closure Before or After Adjuvant Therapy Trial

Stopped: Low accrual - no restart after pandemic suspension

Italy14 participantsStarted 2020-09-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of participants with good compliance to adjuvant therapy

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

Trial details

NCT IDNCT04372992

SponsorOspedale Umberto I di Torino

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-01

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