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Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma

Primary Purpose

Esophageal Cancer

Status
Terminated
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
5-FU
Cisplatin
Taxotere
Cetuximab
Radiation during chemoradio-immunotherapy
Sponsored by
Arbeitsgemeinschaft medikamentoese Tumortherapie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal cancer, Pre-operative, Chemo-immunotherapy, Radiochemo-immunotherapy, EGFR, Radiosensitivity, Resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Landeskrankenhaus Feldkirch
  • Universitätsklinikum Graz
  • Universitätsklinik Innsbruck
  • A.ö. Landeskrankenhaus Leoben
  • Universitaetsklinik f. Innere Medizin III
  • Krankenhaus Barmherzige Brueder St. Veit a.d. Glan
  • Klinikum Kreuzschwestern Wels GmbH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Response rate
Percentage of complete remissions and resection rate

Secondary Outcome Measures

Occurrence of toxicities
Evaluation of Quality of Life

Full Information

First Posted
August 13, 2008
Last Updated
March 6, 2015
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Merck Sharp & Dohme LLC, Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00735345
Brief Title
Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma
Official Title
Chemotherapy Induction and Chemoradiotherapy Combined With Cetuximab Respectively in Patients With Non-Metastatic Esophageal Carcinoma: A Multicentric Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
because of safety concerns the study was terminated prematurely
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Merck Sharp & Dohme LLC, Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients with a locoregional carcinoma of the esophagus or gastro-esophageal junction have a low survival prognosis following surgical resection. In studies published to date no positive effect upon overall survival could be demonstrated for preoperative chemotherapy or chemoradiotherapy. However, patients with a complete remission following preoperative therapy show prolonged survival. This study design is based upon decreasing primary tumour and preventing oder delaying micrometastases by means of a chemo induction therapy, increasing R0 resection rates and preventing local recurrence by means of preoperative chemoradiotherapy, increasing the radiosensitivity of tumour cells through treatment combination with cetuximab, surgical resection of the locoregional primary tumour or definitive radiochemotherapy in case the primary tumour is inoperable. The aim of this study is therefore to evaluate the feasibility and safety of a 3-staged therapy approach including an EGFR antibody in the treatment of patients with potentially resectable esophageal cancer, as well as the evaluation of objective response rates to this preoperative therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophageal cancer, Pre-operative, Chemo-immunotherapy, Radiochemo-immunotherapy, EGFR, Radiosensitivity, Resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
15 mg/m2/d i.v. d1-5, d29-33
Intervention Type
Drug
Intervention Name(s)
Taxotere
Other Intervention Name(s)
Docetaxel
Intervention Description
75 mg/m2/d i.v. d1 and d29, 15 mg/m2/d i.v. on d57, d64, d71 and d78
Intervention Type
Biological
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
Cetuximab: 400 mg/m2 i.v. d1; 250mg/m2 weekly d8 through d85
Intervention Type
Radiation
Intervention Name(s)
Radiation during chemoradio-immunotherapy
Intervention Description
39.6 Gy total dose
Primary Outcome Measure Information:
Title
Response rate
Time Frame
Duration of study
Title
Percentage of complete remissions and resection rate
Time Frame
Duration of study
Secondary Outcome Measure Information:
Title
Occurrence of toxicities
Time Frame
Duration of study
Title
Evaluation of Quality of Life
Time Frame
Duration of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Eisterer, Prof. Dr.
Organizational Affiliation
Medizinische Universitaet Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landeskrankenhaus Feldkirch
City
Feldkirch
ZIP/Postal Code
A-6806
Country
Austria
Facility Name
Universitätsklinikum Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Universitätsklinik Innsbruck
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
A.ö. Landeskrankenhaus Leoben
City
Leoben
ZIP/Postal Code
A-8700
Country
Austria
Facility Name
Universitaetsklinik f. Innere Medizin III
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
Krankenhaus Barmherzige Brueder St. Veit a.d. Glan
City
St. Veit/ Glan
ZIP/Postal Code
A-9300
Country
Austria
Facility Name
Klinikum Kreuzschwestern Wels GmbH
City
Wels
ZIP/Postal Code
A-4600
Country
Austria

12. IPD Sharing Statement

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Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma

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