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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PD Dr Markus Möhler, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT00374985
First received: September 11, 2006
Last updated: November 27, 2014
Last verified: November 2014

September 11, 2006
November 27, 2014
October 2005
September 2013   (final data collection date for primary outcome measure)
maximum tolerable dose and safety [ Time Frame: until August 2010 ] [ Designated as safety issue: Yes ]
  • maximum tolerable dose
  • doselimiting toxicity
  • response rate
Complete list of historical versions of study NCT00374985 on ClinicalTrials.gov Archive Site
Not Provided
  • 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
    weekly doses
  • Procedure: Radiotherapy
    regular fractions
Experimental: one arm
Interventions:
  • Drug: Docetaxel, Oxaliplatin
  • Procedure: Radiotherapy
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.
 
Completed
25
September 2013
September 2013   (final data collection date for primary outcome measure)

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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00374985
GC-DOR-2004
Yes
Not Provided
Not Provided
PD Dr Markus Möhler, Johannes Gutenberg University Mainz
Johannes Gutenberg University Mainz
Not Provided
Principal Investigator: Markus Moehler, MD Johannes Gutenberg University Mainz
Johannes Gutenberg University Mainz
November 2014

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