| General information |
| Database: | DB00408 |
| Objective: | Local and systemic recurrence are important sources of treatment failure following surgical resection of esophageal adenocarcinoma. They hypothesized that adding preoperative cetuximab and radiotherapy (cetuxRT) to perioperative chemotherapy would increase treatment efficacy with acceptable toxicity. |
| Authors: | Ubink I, et al |
| Title: | Adding preoperative radiotherapy plus cetuximab to perioperative chemotherapy for resectable esophageal adenocarcinoma: a singlecenter prospectivephase II trial. |
| Journal: | Oncologist. |
| Year: | 2014 |
| PMID: | 24335595 |
| Trial Design |
| Clinical Trial Id: | NCT00827671 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer |
| Cancer Subtype: | Esophageal Adenocarcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 6 |
| Therapeutic Combination Content: | Adding preoperative radiotherapy plus cetuximab to perioperative chemotherapy |
| Study Type: | SingleCenter Prospectivephase II Trial |
| Key Patients Feature: | Resectable Esophageal Adenocarcinoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were treated with three cycles of epirubicin, cisplatin, and capecitabine (ECX), followed by cetuxRT. After surgery with curative intent, patients received three more cycles of ECX. |
| Primary End Point: | efficacy, determined by histopathological complete response (pCR) rate, and safety, which was assessed with resectability rate. |
| Secondary End Point: | NA |
| Patients Number: | 12 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Addition of cetuxRT was well tolerated and did not interfere with the resectability rate (100%). however, the pCR rate was 0, and 50% of patients experienced serious adverse events (SAEs) postoperatively. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Addition of cetuxRT was well tolerated and did not interfere with the resectability rate (100%). however, the pCR rate was 0, and 50% of patients experienced serious adverse events (SAEs) postoperatively. |
| Conclusions: | With 12 patients enrolled, the lack of initial signs of efficacy and a high incidence of postoperative SAEs prompted us to end this study prematurely. Perioperative ECX was associated with considerable toxicity, and further treatment intensification is problematic. |