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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 11, 2006

Last Updated Date

May 16, 2008

Start Date ^ICMJE

October 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

maximum tolerable dose
doselimiting toxicity
response rate

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00374985 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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).

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Esophageal Neoplasms
Stomach Neoplasms

Intervention ^ICMJE

Drug: Docetaxel, Oxaliplatin
Procedure: Radiotherapy

Study Arm (s)

Not Provided

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Markus Moehler, MD

+49 6131 170

mmoehler@mail.uni-mainz.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00374985

Other Study ID Numbers ^ICMJE

GC-DOR-2004

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Johannes Gutenberg University Mainz

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Markus Moehler, MD

Johannes Gutenberg University Mainz

Information Provided By

Johannes Gutenberg University Mainz

Verification Date

May 2008

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

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