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

This study has been completed.
Information provided by (Responsible Party):
PD Dr Markus Möhler, Johannes Gutenberg University Mainz Identifier:
First received: September 11, 2006
Last updated: November 27, 2014
Last verified: November 2014
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.

Condition Intervention Phase
Esophageal Neoplasms
Stomach Neoplasms
Drug: Docetaxel, Oxaliplatin
Procedure: Radiotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • maximum tolerable dose and safety [ Time Frame: until August 2010 ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: October 2005
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: one arm Drug: Docetaxel, Oxaliplatin
weekly doses
Procedure: Radiotherapy
regular fractions

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).


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00374985

Mainz, Rheinland-Pfalz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Principal Investigator: Markus Moehler, MD Johannes Gutenberg University Mainz
  More Information

No publications provided by Johannes Gutenberg University Mainz

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: PD Dr Markus Möhler, Professor, Johannes Gutenberg University Mainz Identifier: NCT00374985     History of Changes
Other Study ID Numbers: GC-DOR-2004
Study First Received: September 11, 2006
Last Updated: November 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:

Additional relevant MeSH terms:
Esophageal Neoplasms
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Stomach Diseases
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on December 01, 2015