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Open Access Research article

Prospective, open, multi-centre phase I/II trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and oxaliplatin in patients with adenocarcinoma of the oesophagogastric junction

Markus Moehler1*, Ines Gockel1*, Hans-Peter Roessler1, Dirk Arnold2, Tanja Trarbach3, Thomas Thomaidis1, Gunther Klautke4, Claus Rödel5, Baruch Brenner6, Hauke Lang1, Peter R Galle1, Carl C Schimanski1 and Heinz Schmidberger1

Author Affiliations

1 I. Medical Department, Johannes-Gutenberg University Mainz, Langenbeckstr.1, Mainz 55101, Germany

2 IV. Medical Department, University Halle-Wittenberg, Halle, Germany

3 West German Cancer Centre, University Hospital, Essen, Germany

4 Radiotherapy Department, University Rostock, Rostock, Germany

5 Radiotherapy Department, Johann-Wolfgang-Goethe University, Frankfurt, Germany

6 Institute of Oncology, Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petach-Tiqva, and Sackler Faculty of Medicine, Tel-Aviv University, Ramat Aviv, Tel-Aviv, Israel

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BMC Cancer 2013, 13:75  doi:10.1186/1471-2407-13-75

Published: 11 February 2013

Abstract

Background

This phase I/II-trial assessed the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of neoadjuvant radiochemotherapy (RCT) with docetaxel and oxaliplatin in patients with locally advanced adenocarcinoma of the oesophagogastric junction.

Methods

Patients received neoadjuvant radiotherapy (50.4 Gy) together with weekly docetaxel (20 mg/m2 at dose level (DL) 1 and 2, 25 mg/m2 at DL 3) and oxaliplatin (40 mg/m2 at DL 1, 50 mg/m2 at DL 2 and 3) over 5 weeks. The primary endpoint was the DLT and the MTD of the RCT regimen. Secondary endpoints included overall response rate (ORR) and progression-free survival (PFS).

Results

A total of 24 patients were included. Four patients were treated at DL 1, 13 patients at DL 2 and 7 patients at DL 3. The MTD of the RCT was considered DL 2 with docetaxel 20 mg/m2 and oxaliplatin 50 mg/m2. Objective response (CR/PR) was observed in 32% (7/22) of patients. Eighteen patients (75%) underwent surgery after RCT. The median PFS for all patients (n = 24) was 6.5 months. The median overall survival for all patients (n = 24) was 16.3 months. Patients treated at DL 2 had a median overall survival of 29.5 months.

Conclusion

Neoadjuvant RCT with docetaxel 20 mg/m2 and oxaliplatin 50 mg/m2 was effective and showed a good toxicity profile. Future studies should consider the addition of targeted therapies to current neoadjuvant therapy regimens to further improve the outcome of patients with advanced cancer of the oesophagogastric junction.

Trial Registration

NCT00374985

Keywords:
Docetaxel; Neoadjuvant radiochemotherapy; Chemoradiotherapy; Oesophagogastric cancer oxaliplatin