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 1year in patients with stage III colon cancer after radical resection in Taiwan. Following the completion of an adjuvant oxaliplatin-based regimen for 3weeks 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 7days 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disease recurrence, intolerable toxicity, withdrew consent or the investigator determined that the patient should be withdrawn during the study period, they were withdrawn from the study.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.
| Original language | English |
|---|---|
| Article number | 191 |
| Journal | Trials |
| Volume | 18 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Apr 26 2017 |
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Keywords
- Oxaliplatin
- Stage III colon cancer
- Tegafur-uracil
ASJC Scopus subject areas
- Medicine (miscellaneous)
- Pharmacology (medical)
Cite this
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. / Yeh, Yung Sung; Tsai, Hsiang Lin; Huang, Ching Wen; Wei, Po Li; Sung, Yung Chuan; Tang, Hsiu Chih; Wang, Jaw Yuan.
In: Trials, Vol. 18, No. 1, 191, 26.04.2017.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Maintenance tegafur-uracil versus observation following an adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection
T2 - Study protocol for a randomized controlled trial
AU - Yeh, Yung Sung
AU - Tsai, Hsiang Lin
AU - Huang, Ching Wen
AU - Wei, Po Li
AU - Sung, Yung Chuan
AU - Tang, Hsiu Chih
AU - Wang, Jaw Yuan
PY - 2017/4/26
Y1 - 2017/4/26
N2 - 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 1year in patients with stage III colon cancer after radical resection in Taiwan. Following the completion of an adjuvant oxaliplatin-based regimen for 3weeks 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 7days 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.
AB - 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 1year in patients with stage III colon cancer after radical resection in Taiwan. Following the completion of an adjuvant oxaliplatin-based regimen for 3weeks 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 7days 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.
KW - Oxaliplatin
KW - Stage III colon cancer
KW - Tegafur-uracil
UR - http://www.scopus.com/inward/record.url?scp=85018661198&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85018661198&partnerID=8YFLogxK
U2 - 10.1186/s13063-017-1904-9
DO - 10.1186/s13063-017-1904-9
M3 - Article
C2 - 28441966
AN - SCOPUS:85018661198
VL - 18
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 191
ER -