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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Johannes Gutenberg University Mainz.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT00374985
First received: September 11, 2006
Last updated: May 16, 2008
Last verified: May 2008
  Purpose

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
  • doselimiting toxicity
  • response rate

Secondary Outcome Measures:
  • complications due to surgery and post-surgery
  • ability for resection after radiochemotherapy
  • rates of local recurrence and distant metastasis
  • 1-year and 2-year survival
  • toxicity of neoadjuvant radiochemotherapy
  • Quality of Life

Estimated Enrollment: 30
Study Start Date: October 2005
Estimated Study Completion Date: December 2009
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).

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374985

Contacts
Contact: Markus Moehler, MD +49 6131 170 mmoehler@mail.uni-mainz.de

Locations
Germany
Johannes-Gutenberg-Universität Recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact: Markus Möhler, MD    0049 6131 17 5712    moehler@mail.uni-mainz.de   
Principal Investigator: Markus Möhler, MD         
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00374985     History of Changes
Other Study ID Numbers: GC-DOR-2004
Study First Received: September 11, 2006
Last Updated: May 16, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:
chemoradiation
docetaxel
oxaliplatin
gastric
neoadjuvant
radiochemotherapy

Additional relevant MeSH terms:
Neoplasms
Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Docetaxel
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014