Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 11, 2006
May 16, 2008
October 2005
Not Provided
  • maximum tolerable dose
  • doselimiting toxicity
  • response rate
Same as current
Complete list of historical versions of study NCT00374985 on ClinicalTrials.gov Archive Site
  • 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
  • complications due to surgery and post-surgery
  • ability for resection after radiochemotherapy
  • rates of local recurrence and distant metsastasis
  • 1-year and 2-year survival
  • toxicity of neoadjuvant radiochemotherapy
  • Quality of Life
Not Provided
Not Provided
 
Safety and Efficacy of Neoadjuvant Radiochemotherapy in Adenocarcinoma of the Gastric-Oesophageal Junction
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

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.

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).

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Drug: Docetaxel, Oxaliplatin
  • Procedure: Radiotherapy
Not Provided
Moehler M, Gockel I, Roessler HP, Arnold D, Trarbach T, Thomaidis T, Klautke G, Rödel C, Brenner B, Lang H, Galle PR, Schimanski CC, Schmidberger H. Prospective, open, multi-centre phase I/II trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and oxaliplatin in patients with adenocarcinoma of the oesophagogastric junction. BMC Cancer. 2013 Feb 11;13:75. doi: 10.1186/1471-2407-13-75.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2009
Not Provided

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
Both
18 Years to 75 Years
No
Contact: Markus Moehler, MD +49 6131 170 mmoehler@mail.uni-mainz.de
Germany
 
NCT00374985
GC-DOR-2004
Yes
Not Provided
Johannes Gutenberg University Mainz
Not Provided
Principal Investigator: Markus Moehler, MD Johannes Gutenberg University Mainz
Johannes Gutenberg University Mainz
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP