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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Esophageal Neoplasms, Stomach Neoplasms

Intervention / Treatment
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* Drug: Docetaxel, Oxaliplatin
* Procedure: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one arm<br> | Drug: Docetaxel, Oxaliplatin<br>* weekly doses<br>Procedure: Radiotherapy<br>* regular fractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum tolerable dose and safety |  | until August 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemoradiation, docetaxel, oxaliplatin, gastric, neoadjuvant, radiochemotherapy