Prospective, Open, Multicentre Phase I/II Study to Evaluate the Safety and Efficacy of a Neoadjuvant Radiochemotherapy With Docetaxel and Oxalipaltin in Patients With Adenocarcinoma of the Gastric-Oesophageal Junction
Radiotherapy starts on day 1 of chemotherapy after the application of Docetaxel and
Oxaliplatin and will be administered in single doses of 1.8 Gy once daily and five times a
week for 5 weeks.
In the sixth treatment week a boost of 3 further radiations with 1.8 Gy will be applied.
Initially, in part A of the study the maximum tolerable dose (MTD) for the simultaneous
chemotherapy will be identified with a 3-step dose escalation scheme:
Level 1: Docetaxel: 20 mg/m2 Oxaliplatin 40 mg/m2 i.v., Level 2: Docetaxel: 20 mg/m2
Oxaliplatin 50 mg/m2 i.v., Level 3: Docetaxel: 25 mg/m2 Oxaliplatin 50 mg/m2 i.v.,
The treatment starts with 3 patients in level 1. If no dose limiting toxicities appear, it
will be switched to dose level 2. The same applies for the switch from level 2 to level 3.
If a DLT appears on one level, a further 3 patients will be treated within this dose level.
If in one level at least 2 of 6 patients show DLT, the subjacent level will be defined as
the maximum tolerable dose (MTD).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
maximum tolerable dose
Markus Moehler, MD
Johannes Gutenberg University Mainz
Germany: Federal Institute for Drugs and Medical Devices