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.

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/m(2) at dose level (DL) 1 and 2, 25 mg/m(2) at DL 3) and oxaliplatin (40 mg/m(2) at DL 1, 50 mg/m(2) 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. T

SUBMITTER: Moehler M 

PROVIDER: S-EPMC3579685 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature