NCT00374985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2006

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

7.9 years

First QC Date

September 11, 2006

Last Update Submit

November 27, 2014

Conditions

Esophageal NeoplasmsStomach Neoplasms

Keywords

chemoradiationdocetaxeloxaliplatingastricneoadjuvantradiochemotherapy

Outcome Measures

Primary Outcomes (1)

  • maximum tolerable dose and safety

    until August 2010

Study Arms (1)

one arm

EXPERIMENTAL
Drug: Docetaxel, OxaliplatinProcedure: Radiotherapy

Interventions

Docetaxel, OxaliplatinDRUG

weekly doses

one arm
RadiotherapyPROCEDURE

regular fractions

one arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adenocarcinoma of gastric-esophagal junction
  • stage II to III
  • unidimensional measurable disease

You may not qualify if:

  • surgery of primary tumor
  • metastasis
  • prior chemo- or radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes-Gutenberg-Universität

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (1)

  • 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.

    PMID: 23394629DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsStomach Neoplasms

Interventions

DocetaxelOxaliplatinRadiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesTherapeutics

Study Officials

  • Markus Moehler, MD

    Johannes Gutenberg University Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 12, 2006

Study Start

October 1, 2005

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

DE(1)