Abstract | BACKGROUND: PATIENTS AND METHODS: Eligible patients are aged 20 to 79 years with an ECOG performance status of 0-1 and histologically/cytologically confirmed RAS wild-type mCRC. A total of 800 patients are to be randomly assigned (1:1 ratio) to mFOLFOX6 plus panitumumab (n = 400) or bevacizumab (n = 400) and stratified according to institution, age (20-64 vs. 65-79 years), and liver metastases (present vs. absent). Each treatment regimen includes oxaliplatin 85 mg/m2, l- leucovorin 200 mg/m2, and 5-fluorouracil (5-FU) I.V. 400 mg/m2 on day 1; 5-FU continuous I.V. 2400 mg/m2 on days 1 to 3; and either panitumumab 6 mg/kg or bevacizumab 5 mg/kg on day 1 every 2 weeks. The primary endpoint is overall survival forming the basis to detect a hazard ratio of 0.76 with a 1-sided type I error rate of 0.025 and 80% power. Secondary efficacy endpoints include progression-free survival, response rate, duration of response, and curative resection rate. A comprehensive biomarker analysis (NCT02394834) using archival tumor tissue and circulating tumor DNA samples collected at different time points (pretreatment and confirmed progressive disease) will investigate potential biomarkers related to primary and secondary resistance. The first patient was enrolled in May 2015 and the study is anticipated to complete in 2020.
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Authors | Takayuki Yoshino, Hiroyuki Uetake, Katsuya Tsuchihara, Kohei Shitara, Kentaro Yamazaki, Eiji Oki, Takeo Sato, Takeshi Naitoh, Yoshito Komatsu, Takeshi Kato, Kazunori Yamanaka, Kouji Iwasaki, Jumpei Soeda, Masamitsu Hihara, Takeharu Yamanaka, Atsushi Ochiai, Kei Muro |
Journal | Clinical colorectal cancer
(Clin Colorectal Cancer)
Vol. 16
Issue 2
Pg. 158-163
(06 2017)
ISSN: 1938-0674 [Electronic] United States |
PMID | 28237539
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial)
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Copyright | Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Antibodies, Monoclonal
- Organoplatinum Compounds
- Bevacizumab
- Panitumumab
- ras Proteins
- Leucovorin
- Fluorouracil
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Topics |
- Adult
- Age Factors
- Aged
- Antibodies, Monoclonal
(administration & dosage)
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage)
- Bevacizumab
(administration & dosage)
- Colorectal Neoplasms
(drug therapy, genetics, pathology)
- Disease-Free Survival
- Fluorouracil
(administration & dosage)
- Humans
- Leucovorin
(administration & dosage)
- Liver Neoplasms
(secondary)
- Middle Aged
- Neoplasm Metastasis
- Organoplatinum Compounds
(administration & dosage)
- Panitumumab
- Research Design
- Survival Rate
- Young Adult
- ras Proteins
(genetics)
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