NCT00735345

Brief Summary

The aim of this study is the evaluate the feasibility and safety of chemotherapy induction treatment combined with cetuximab followed by chemoradiotherapy combined with cetuximab in the treatment of patients with non-metastatic esophageal cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2008

Typical duration for phase_2

Geographic Reach
1 country

7 active sites

Status
terminated

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

August 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

4.3 years

First QC Date

August 13, 2008

Last Update Submit

March 6, 2015

Conditions

Esophageal Cancer

Keywords

Esophageal cancerPre-operativeChemo-immunotherapyRadiochemo-immunotherapyEGFRRadiosensitivityResection

Outcome Measures

Primary Outcomes (2)

  • Response rate

    Duration of study

  • Percentage of complete remissions and resection rate

    Duration of study

Secondary Outcomes (2)

  • Occurrence of toxicities

    Duration of study

  • Evaluation of Quality of Life

    Duration of study

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy

Drug: 5-FUDrug: CisplatinDrug: TaxotereBiological: CetuximabRadiation: Radiation during chemoradio-immunotherapy

Interventions

5-FUDRUG

750 mg/m2/d C.I. i.v.d1-5, d29-33 and 300 mg/m2/d C.I. i.v. on the days of radiotherapy

Treatment Arm
CisplatinDRUG

15 mg/m2/d i.v. d1-5, d29-33

Treatment Arm
TaxotereDRUG

75 mg/m2/d i.v. d1 and d29, 15 mg/m2/d i.v. on d57, d64, d71 and d78

Also known as: Docetaxel
Treatment Arm
CetuximabBIOLOGICAL

Cetuximab: 400 mg/m2 i.v. d1; 250mg/m2 weekly d8 through d85

Also known as: Erbitux
Treatment Arm
Radiation during chemoradio-immunotherapyRADIATION

39.6 Gy total dose

Treatment Arm

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent
  • histologically confirmed esophageal cancer (squamous cell carcinoma)
  • measurable, non-metastatic disease (uT1-4)
  • no previous cancer therapy (chemotherapy, radiotherapy or resection)
  • life expectancy \> 3 months
  • age \> 18 years
  • WHO Status ≤ 2
  • negative pregnancy test for women of child-bearing potential, and use of adequate contraception
  • hematological status: neutrophiles ≥ 1,5x10E9/L, thrombocytes ≥ 100x10E9/L
  • adequate renal function: serum creatinine ≤ 1,5 x ULN
  • adequate liver function: alkaline phosphatase \< 2,5 x ULN, total bilirubin \< 1,5 x ULN

You may not qualify if:

  • pregnant or nursing women
  • women of child-bearing potential without adequate contraception
  • concomitant anti-tumoral therapy except study mandated procedures
  • cervical esophageal cancer or diagnosis of metastases
  • participation in other clinical trials within the last 30 days
  • history of malignant disease within the last 5 years
  • peripheral neuropathy (NCI CTC ≥ grade 1)
  • concurrent active and serious non-malignant diseases: uncontrolled heart insufficiency, angina pectoris, hypertension or arrhythmias, liver disease, significant neurological or psychiatric conditions
  • active infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Landeskrankenhaus Feldkirch

Feldkirch, A-6806, Austria

Location

Universitätsklinikum Graz

Graz, A-8036, Austria

Location

Universitätsklinik Innsbruck

Innsbruck, A-6020, Austria

Location

A.ö. Landeskrankenhaus Leoben

Leoben, A-8700, Austria

Location

Krankenhaus Barmherzige Brueder St. Veit a.d. Glan

Saint Veit/ Glan, A-9300, Austria

Location

Universitaetsklinik f. Innere Medizin III

Salzburg, A-5020, Austria

Location

Klinikum Kreuzschwestern Wels GmbH

Wels, A-4600, Austria

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

FluorouracilCisplatinDocetaxelCetuximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Wolfgang Eisterer, Prof. Dr.

    Medizinische Universitaet Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 14, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations

AU(7)