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
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 tox...
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| Format: | Article |
| Language: | English |
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BMC
2017-04-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-1904-9 |
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| author | Yung-Sung Yeh Hsiang-Lin Tsai Ching-Wen Huang Po-Li Wei Yung-Chuan Sung Hsiu-Chih Tang Jaw-Yuan Wang |
| author_facet | Yung-Sung Yeh Hsiang-Lin Tsai Ching-Wen Huang Po-Li Wei Yung-Chuan Sung Hsiu-Chih Tang Jaw-Yuan Wang |
| author_sort | Yung-Sung Yeh |
| collection | DOAJ |
| description | 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disease recurrence, intolerable toxicity, withdrew consent or the investigator determined that the patient should be withdrawn during the study period, they were withdrawn from the study.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. |
| first_indexed | 2024-12-19T03:06:57Z |
| format | Article |
| id | doaj.art-d82fd165302b46f3abcf39aaa7c88cea |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-19T03:06:57Z |
| publishDate | 2017-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-d82fd165302b46f3abcf39aaa7c88cea2022-12-21T20:38:05ZengBMCTrials1745-62152017-04-0118111310.1186/s13063-017-1904-9Maintenance 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 trialYung-Sung Yeh0Hsiang-Lin Tsai1Ching-Wen Huang2Po-Li Wei3Yung-Chuan Sung4Hsiu-Chih Tang5Jaw-Yuan Wang6Division of Trauma and Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical UniversityDivision of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical UniversityDivision of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical UniversityDivision of Colorectal Surgery, Department of Surgery, Taipei Medical University Hospital, Taipei Medical UniversityColon and Rectal Surgery, Tainan Sin-Lau HospitalDivision of Hematology-Oncology, Department of Internal Medicine, Cathay General HospitalDivision of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical UniversityAbstract 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.http://link.springer.com/article/10.1186/s13063-017-1904-9Tegafur-uracilOxaliplatinStage III colon cancer |
| spellingShingle | Yung-Sung Yeh Hsiang-Lin Tsai Ching-Wen Huang Po-Li Wei Yung-Chuan Sung Hsiu-Chih Tang Jaw-Yuan Wang 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 Trials Tegafur-uracil Oxaliplatin Stage III colon cancer |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Tegafur-uracil Oxaliplatin Stage III colon cancer |
| url | http://link.springer.com/article/10.1186/s13063-017-1904-9 |
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