Feasibility study of nivolumab as neoadjuvant chemotherapy for locally esophageal carcinoma: FRONTiER (JCOG1804E)
- 1 July 2020
- journal article
- research article
- Published by Future Medicine Ltd in Future Oncology
- Vol. 16 (19), 1351-1357
- https://doi.org/10.2217/fon-2020-0189
Abstract
One of the standard treatments of resectable esophageal squamous cell carcinoma (ESCC) is neoadjuvant chemotherapy followed by surgery. Nivolumab showed efficacy for metastatic ESCC. However, the safety and efficacy of neoadjuvant nivolumab with chemotherapy for ESCC is unknown. Therefore, we will conduct FRONTiER to evaluate the safety and efficacy of nivolumab adding to neoadjuvant chemotherapy. FRONTiER comprises four experimental cohorts: (A) including nivolumab plus 5-FU+CDDP (cisplatin and 5-fluorouracil [CF]); (B) including one prior administration of nivolumab and the cohort A regimen; (C) including nivolumab plus docetaxel+ CF; (D) including one prior administration of nivolumab and the cohort C regimen; an expanded cohort. The primary end point is the incidence of dose-limiting toxicities from the initial dose to the 30th postoperative day. Clinical Trial Identifier: NCT03914443Keywords
This publication has 17 references indexed in Scilit:
- Phase II feasibility study of preoperative concurrent chemoradiotherapy with cisplatin plus 5-fluorouracil and elective lymph node irradiation for clinical stage II/III esophageal squamous cell carcinomaInternational Journal of Clinical Oncology, 2018
- 8th edition AJCC/UICC staging of cancers of the esophagus and esophagogastric junction: application to clinical practiceAnnals of Cardiothoracic Surgery, 2017
- Comprehensive Registry of Esophageal Cancer in Japan, 2009Esophagus, 2016
- The epidemic of oesophageal carcinoma: Where are we now?Cancer Epidemiology, 2016
- Prognostic Factors in Patients Receiving Neoadjuvant 5-Fluorouracil plus Cisplatin for Advanced Esophageal Cancer (JCOG9907)Oncology, 2015
- Phase II feasibility study of preoperative chemotherapy with docetaxel, cisplatin, and fluorouracil for esophageal squamous cell carcinomaCancer Science, 2013
- Three-arm Phase III Trial Comparing Cisplatin Plus 5-FU (CF) Versus Docetaxel, Cisplatin Plus 5-FU (DCF) Versus Radiotherapy with CF (CF-RT) as Preoperative Therapy for Locally Advanced Esophageal Cancer (JCOG1109, NExT Study)Japanese Journal of Clinical Oncology, 2013
- A Randomized Trial Comparing Postoperative Adjuvant Chemotherapy with Cisplatin and 5-Fluorouracil Versus Preoperative Chemotherapy for Localized Advanced Squamous Cell Carcinoma of the Thoracic Esophagus (JCOG9907)Annals of Surgical Oncology, 2011
- Phase I Study of Single-Agent Anti–Programmed Death-1 (MDX-1106) in Refractory Solid Tumors: Safety, Clinical Activity, Pharmacodynamics, and Immunologic CorrelatesJournal of Clinical Oncology, 2010
- Surgery Plus Chemotherapy Compared With Surgery Alone for Localized Squamous Cell Carcinoma of the Thoracic Esophagus: A Japan Clinical Oncology Group Study—JCOG9204Journal of Clinical Oncology, 2003