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

Autor: Ching-Wen Huang, Jaw-Yuan Wang, Po Li Wei, Hsiu Chih Tang, Yung Chuan Sung, Yung Sung Yeh, Hsiang Lin Tsai
Rok vydání: 2017
Předmět:
Male
Time Factors
Organoplatinum Compounds
medicine.medical_treatment
Medicine (miscellaneous)
Tegafur/uracil
law.invention
Study Protocol
0302 clinical medicine
Clinical Protocols
Maintenance therapy
Randomized controlled trial
Risk Factors
law
Antineoplastic Combined Chemotherapy Protocols
Pharmacology (medical)
Prospective Studies
030212 general & internal medicine
Colectomy
Aged
80 and over
lcsh:R5-920
Middle Aged
Oxaliplatin
Treatment Outcome
Chemotherapy
Adjuvant
Research Design
030220 oncology & carcinogenesis
Colonic Neoplasms
Disease Progression
Female
lcsh:Medicine (General)
Adjuvant
medicine.drug
Adult
Antimetabolites
Antineoplastic
medicine.medical_specialty
Randomization
Taiwan
Disease-Free Survival
Maintenance Chemotherapy
Young Adult
03 medical and health sciences
medicine
Humans
Aged
Neoplasm Staging
Tegafur
business.industry
Cancer
medicine.disease
Survival Analysis
Tegafur-uracil
Surgery
Regimen
Feasibility Studies
Stage III colon cancer
Neoplasm Recurrence
Local
business
Zdroj: Trials, Vol 18, Iss 1, Pp 1-13 (2017)
Trials
ISSN: 1745-6215
DOI: 10.1186/s13063-017-1904-9
Popis: 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. 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.
Databáze: OpenAIRE
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