Safety and Efficacy of Neoadjuvant Radiochemotherapy in Adenocarcinoma of the Gastric-oesophageal Junction

Phase 1

Completed

• Conditions: Esophageal Neoplasms; Stomach Neoplasms
• Interventions: Drug: Docetaxel, Oxaliplatin; Procedure: Radiotherapy

• Registration Number: NCT00374985
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

The purpose of this study is to determine the dose limiting toxicity and the maximum tolerable dose of the radiochemotherapy with Docetaxel and Oxaliplatin in patients with adenocarcinoma of the gastric-oesophageal junction.

Detailed Description

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.

Simultaneous chemotherapy:

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).

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-09-11
• Study First Submitted QC: 2006-09-11
• Study First Posted: 2006-09-12
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-27
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• adenocarcinoma of gastric-esophagal junction
• stage II to III
• unidimensional measurable disease

Exclusion Criteria

• surgery of primary tumor
• metastasis
• prior chemo- or radiotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
one arm	Docetaxel, Oxaliplatin	-
one arm	Radiotherapy	-

Primary Outcome Measures

Name	Time	Method
maximum tolerable dose and safety	until August 2010

Trial Locations

Locations (1)

Johannes-Gutenberg-Universität; 🇩🇪 Mainz, Rheinland-Pfalz, Germany