First-line single-agent panitumumab in frail elderly patients with wild-type RAS unresectable colorectal cancer: a phase II study protocol OGSG 1602
Abstract Background A cytotoxic chemotherapeutic regimen is not routinely recommended for frail elderly patients with unresectable colorectal cancer (CRC) because of susceptibility to treatment. Panitumumab is a monoclonal antibody targeting the epidermal growth factor receptor (EGFR). Use of panitu...
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| Format: | Article |
| Language: | English |
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BMC
2019-06-01
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| Series: | BMC Cancer |
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| Online Access: | http://link.springer.com/article/10.1186/s12885-019-5821-z |
| _version_ | 1811211091338854400 |
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| author | Tetsuji Terazawa Takeshi Kato Masahiro Goto Daisuke Sakai Yukinori Kurokawa Toshio Shimokawa Yoshihiro Matsubara Taroh Satoh |
| author_facet | Tetsuji Terazawa Takeshi Kato Masahiro Goto Daisuke Sakai Yukinori Kurokawa Toshio Shimokawa Yoshihiro Matsubara Taroh Satoh |
| author_sort | Tetsuji Terazawa |
| collection | DOAJ |
| description | Abstract Background A cytotoxic chemotherapeutic regimen is not routinely recommended for frail elderly patients with unresectable colorectal cancer (CRC) because of susceptibility to treatment. Panitumumab is a monoclonal antibody targeting the epidermal growth factor receptor (EGFR). Use of panitumumab as first-line therapy is expected to be well tolerated and to improve survival rates, even in patients who are not eligible for intensive chemotherapy. However, the efficacy and safety of panitumumab as the first-line therapy for the frail elderly patients with unresectable CRC have not been yet studied. Methods We plan to conduct a prospective multi-center phase II study. Patients with wild-type RAS unresectable CRC aged ≥76 years or ≥ 65 who are not considered eligible for intensive chemotherapy will be included in the study. A total of 36 patients will be enrolled from Osaka Gastrointestinal Cancer Chemotherapy Study Group for over 2 years. Panitumumab 6 mg/kg IV infusion will be administered every 2 weeks. The purpose of this trial is to assess the efficacy of panitumumab as first-line therapy for patients with unresectable CRC. The primary endpoint is to determine the disease control rate. Secondary endpoints include progression-free survival, overall survival, response rate, time to treatment failure, and the incidence of grade 3/4 toxicities. Discussion This is a prospective phase II trial assessing the efficacy of panitumumab monotherapy in the elderly patients with wild-type RAS unresectable CRC. Trial registration The ethics committee of the Osaka Medical College approved this study on November 7, 2016. The trial registration number of the government was UMIN000024528 on December 1, 2016. It was registered prospectively (the day of enrollment of the first participant was February 9, 2017). |
| first_indexed | 2024-04-12T05:06:46Z |
| format | Article |
| id | doaj.art-2633da71f54a4a608ce4d63070f9d032 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-04-12T05:06:46Z |
| publishDate | 2019-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-2633da71f54a4a608ce4d63070f9d0322022-12-22T03:46:51ZengBMCBMC Cancer1471-24072019-06-011911510.1186/s12885-019-5821-zFirst-line single-agent panitumumab in frail elderly patients with wild-type RAS unresectable colorectal cancer: a phase II study protocol OGSG 1602Tetsuji Terazawa0Takeshi Kato1Masahiro Goto2Daisuke Sakai3Yukinori Kurokawa4Toshio Shimokawa5Yoshihiro Matsubara6Taroh Satoh7Cancer Chemotherapy Center, Osaka medical collegeDepartment of Gastroenterological Surgery, Osaka National HospitalCancer Chemotherapy Center, Osaka medical collegeDepartment of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of MedicineDepartment of Gastroenterological Surgery, Osaka University Graduate School of MedicineClinical Study Support Center, Wakayama Medical UniversityBiostatistical Research AssociationDepartment of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of MedicineAbstract Background A cytotoxic chemotherapeutic regimen is not routinely recommended for frail elderly patients with unresectable colorectal cancer (CRC) because of susceptibility to treatment. Panitumumab is a monoclonal antibody targeting the epidermal growth factor receptor (EGFR). Use of panitumumab as first-line therapy is expected to be well tolerated and to improve survival rates, even in patients who are not eligible for intensive chemotherapy. However, the efficacy and safety of panitumumab as the first-line therapy for the frail elderly patients with unresectable CRC have not been yet studied. Methods We plan to conduct a prospective multi-center phase II study. Patients with wild-type RAS unresectable CRC aged ≥76 years or ≥ 65 who are not considered eligible for intensive chemotherapy will be included in the study. A total of 36 patients will be enrolled from Osaka Gastrointestinal Cancer Chemotherapy Study Group for over 2 years. Panitumumab 6 mg/kg IV infusion will be administered every 2 weeks. The purpose of this trial is to assess the efficacy of panitumumab as first-line therapy for patients with unresectable CRC. The primary endpoint is to determine the disease control rate. Secondary endpoints include progression-free survival, overall survival, response rate, time to treatment failure, and the incidence of grade 3/4 toxicities. Discussion This is a prospective phase II trial assessing the efficacy of panitumumab monotherapy in the elderly patients with wild-type RAS unresectable CRC. Trial registration The ethics committee of the Osaka Medical College approved this study on November 7, 2016. The trial registration number of the government was UMIN000024528 on December 1, 2016. It was registered prospectively (the day of enrollment of the first participant was February 9, 2017).http://link.springer.com/article/10.1186/s12885-019-5821-zColorectal cancerFrail patientPanitumumabClinical trial-trial design |
| spellingShingle | Tetsuji Terazawa Takeshi Kato Masahiro Goto Daisuke Sakai Yukinori Kurokawa Toshio Shimokawa Yoshihiro Matsubara Taroh Satoh First-line single-agent panitumumab in frail elderly patients with wild-type RAS unresectable colorectal cancer: a phase II study protocol OGSG 1602 BMC Cancer Colorectal cancer Frail patient Panitumumab Clinical trial-trial design |
| title | First-line single-agent panitumumab in frail elderly patients with wild-type RAS unresectable colorectal cancer: a phase II study protocol OGSG 1602 |
| title_full | First-line single-agent panitumumab in frail elderly patients with wild-type RAS unresectable colorectal cancer: a phase II study protocol OGSG 1602 |
| title_fullStr | First-line single-agent panitumumab in frail elderly patients with wild-type RAS unresectable colorectal cancer: a phase II study protocol OGSG 1602 |
| title_full_unstemmed | First-line single-agent panitumumab in frail elderly patients with wild-type RAS unresectable colorectal cancer: a phase II study protocol OGSG 1602 |
| title_short | First-line single-agent panitumumab in frail elderly patients with wild-type RAS unresectable colorectal cancer: a phase II study protocol OGSG 1602 |
| title_sort | first line single agent panitumumab in frail elderly patients with wild type ras unresectable colorectal cancer a phase ii study protocol ogsg 1602 |
| topic | Colorectal cancer Frail patient Panitumumab Clinical trial-trial design |
| url | http://link.springer.com/article/10.1186/s12885-019-5821-z |
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