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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00374985
Other study ID # GC-DOR-2004
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 11, 2006
Last updated November 27, 2014
Start date October 2005
Est. completion date September 2013

Study information

Verified date November 2014
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

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


Intervention

Drug:
Docetaxel, Oxaliplatin
weekly doses
Procedure:
Radiotherapy
regular fractions

Locations

Country Name City State
Germany Johannes-Gutenberg-Universität Mainz Rheinland-Pfalz

Sponsors (1)

Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary maximum tolerable dose and safety until August 2010 Yes
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