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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

Maintenance tegafur-uracil versus observation following an adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection: study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Yung-Sung Yeh, Hsiang-Lin Tsai, Ching-Wen Huang, Po-Li Wei, Yung-Chuan Sung, Hsiu-Chih Tang, Jaw-Yuan Wang
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-1904-9) contains supplementary material, which is available to authorized users.

Abstract

Background

We conducted a prospective randomized study of an adjuvant oxaliplatin-based regimen plus orally administered tegafur-uracil in patients with stage III colon cancer after radical resection to evaluate the feasibility of this drug combination in cancer clinical outcomes, acute toxicity, disease-free survival (DFS), and overall survival (OS) in Taiwan.

Methods/design

This is an open-label, randomized, comparative, double-arm, multicenter, phase III study to assess DFS, OS, and safety profiles of the aforementioned drug combination as maintenance therapy for 1 year in patients with stage III colon cancer after radical resection in Taiwan. Following the completion of an adjuvant oxaliplatin-based regimen for 3 weeks with no evident disease recurrence, all eligible patients will be randomly assigned to either arm A (maintenance therapy) or arm B (observation arm) in a 2:1 ratio (364 and 182 patients in the tegafur-uracil and observation groups, respectively). Treatment in arm A will be started within 7 days of randomization. If the patients reported disease recurrence, intolerable toxicity, withdrew consent or the investigator determined that the patient should be withdrawn during the study period, they were withdrawn from the study. If a patient was discontinued from the study, the corresponding data were not reused, and the patient was not allowed to re-enter the study.

Discussion

A unique characteristic of this intervention was that the adjuvant chemotherapy with oxaliplatin and tegafur-uracil was anticipated to be safe and has high treatment efficacy, with the advantage of yielding a favorable response rate and tolerable toxicity profile.

Trial registration

ClinicalTrials.gov, identifier: NCT02836977. Registered on 18 July 2016.
Zusatzmaterial
Additional file 1: Submission of a populated SPIRIT Checklist [ 16, 17]. This is an open-label, randomized, multicenter study of tegafur-uracil following adjuvant oxaliplatin-based regimen in patients with stage III colon cancer patients after radical resection. (PDF 53 kb)
Literatur
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