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Esophageal CancerPhase 2NCT00735345

Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma

A Phase 2 study testing 5-FU, Cisplatin and Taxotere in people with Esophageal Cancer, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 7 sites in Austria.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
5-FU, Cisplatin and Taxotere
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
7 sitesAustria
Study dates
Aug 2008to Dec 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Austria7 sites

  • Landeskrankenhaus Feldkirch

    Feldkirch, A-6806

  • Universitätsklinikum Graz

    Graz, A-8036

  • Universitätsklinik Innsbruck

    Innsbruck, A-6020

  • A.ö. Landeskrankenhaus Leoben

    Leoben, A-8700

  • Krankenhaus Barmherzige Brueder St. Veit a.d. Glan

    Saint Veit/ Glan, A-9300

  • Universitaetsklinik f. Innere Medizin III

    Salzburg, A-5020

  • Klinikum Kreuzschwestern Wels GmbH

    Wels, A-4600

Other trials in Austria

About this study

Official title: Chemotherapy Induction and Chemoradiotherapy Combined With Cetuximab Respectively in Patients With Non-Metastatic Esophageal Carcinoma: A Multicentric Phase II Study

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.

Read the 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.

Being tested
5-FU, Cisplatin, Taxotere, Cetuximab, Radiation during chemoradio-immunotherapy
Keywords
Esophageal cancer, Pre-operative, Chemo-immunotherapy, Radiochemo-immunotherapy, EGFR, Radiosensitivity, Resection
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • CisplatinDrug

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

  • TaxotereDrug

    Also called Docetaxel

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

  • CetuximabBiological

    Also called Erbitux

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

  • Radiation during chemoradio-immunotherapyRadiation

    39.6 Gy total dose

Study groups in NCT00735345
Study groupRoleWhat they receive
Treatment ArmExperimentalChemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
Receives: Drug: 5-FU; Drug: Cisplatin; Drug: Taxotere; Biological: Cetuximab; Radiation: Radiation during chemoradio-immunotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    Measured: Duration of study

  2. Percentage of complete remissions and resection rate

    Measured: Duration of study

Secondary outcomes (2)

  1. Occurrence of toxicities

    Measured: Duration of study

  2. Evaluation of Quality of Life

    Measured: Duration of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionDec 2012
  4. Study completionDec 2012

Why it stopped: because of safety concerns the study was terminated prematurely

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00735345
Sponsor's protocol ID
AGMT_ECa
Other IDs
EudraCT Nr. 2008-001016-21
Status last verified
Mar 2015
First submitted
13 Aug 2008
Last updated
9 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5-FU, Cisplatin and Taxotere in people with Esophageal Cancer, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 7 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: because of safety concerns the study was terminated prematurely). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: Duration of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00735345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.

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