Safety and Efficacy of Neoadjuvant Radiochemotherapy in Adenocarcinoma of the Gastric-oesophageal Junction
NCT ID: NCT00374985
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2005-10-31
2013-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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one arm
Docetaxel, Oxaliplatin
weekly doses
Radiotherapy
regular fractions
Interventions
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Docetaxel, Oxaliplatin
weekly doses
Radiotherapy
regular fractions
Eligibility Criteria
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Inclusion Criteria
* stage II to III
* unidimensional measurable disease
Exclusion Criteria
* metastasis
* prior chemo- or radiotherapy
18 Years
75 Years
ALL
No
Sponsors
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Johannes Gutenberg University Mainz
OTHER
Responsible Party
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PD Dr Markus Möhler
Professor
Principal Investigators
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Markus Moehler, MD
Role: PRINCIPAL_INVESTIGATOR
Johannes Gutenberg University Mainz
Locations
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Johannes-Gutenberg-Universität
Mainz, Rhineland-Palatinate, Germany
Countries
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References
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Moehler M, Gockel I, Roessler HP, Arnold D, Trarbach T, Thomaidis T, Klautke G, Rodel 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.
Other Identifiers
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GC-DOR-2004
Identifier Type: -
Identifier Source: org_study_id