Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005512

Trial Description

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Title

Definitive Radiochemotherapy With 5-FU / Cisplatin Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer: a Phase II Study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Esophageal cancer is a highly aggressive tumor. Treatment options are various and range from
chemotherapy to radiotherapy and several surgical techniques. Nevertheless, the overall
survival rates for this disease remain poor.

During the last years the combination of cetuximab with standard chemotherapy or
radiotherapy has mainly be investigated in clinical trials focusing on colorectal and/or
head and neck cancer.

The results obtained from theses studies were very encouraging and led to the initiation of
active clinical research in esophageal cancer patients with antibody inhibition of the EGFR.

The first data in this indication are encouraging showing that cetuximab can safely be added
to chemoradiation for esophageal cancer patients with first hints of efficacy.

Based on the experiences with cetuximab in colorectal cancer and in combination with
radiotherapy in head and neck cancer, the aim of the present study is to evaluate the
feasibility of a combined treatment of cetuximab with continuous infusional 5-FU, cisplatin
and radiotherapy in patients with esophageal cancer and to assess if the overall survival
rates can be increased by addition of an EGFR-targeted therapy.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005512
  •   2014/01/16
  •   2013/02/05
  •   yes
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Secondary IDs

  •   2010-023427-18 
  •   NCT01787006  (ClinicalTrials.gov)
  •   LEOPARD II  (University of Schleswig-Holstein)
  •   2010-023427-18 
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Health Condition or Problem studied

  •   Esophageal Cancer
  •   C15 -  Malignant neoplasm of oesophagus
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Interventions/Observational Groups

  •   Drug: Cetuximab
  •   Drug: Cisplatin, 5-FU
  •   Radiation: Radiotherapy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- 2-year survival; time frame: 2 years

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Secondary Outcome

- 1-year survival; time frame: 1 year
- Progression free Survival; time frame: 1 year
- Progression free Survival; time frame: 2 years
- Overall incidence of patients with adverse events; time frame: 3 years; NCI-CTC 4.0
- Metastasis free survival; time frame: 1 year
- Metastasis free survival; time frame: 2 years
- Response rate; time frame: after 4.5 weeks, after 14 weeks; Tumor assessment CT/MRT Thorax and Abdomen
- Rate of local tumor control; time frame: 1 year
- Rate of local tumor control; time frame: 2 years
- Quality of Life; time frame: 14 weeks; EORTC QLQ-C30 and QLQ OES18

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2011/09/30
  •   134
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Dated and signed written informed consent

- Male or female patients between 18 years and 75 years; patients > 75 years if their
karnofsky performance status is ≥ 80.

- Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus
which is not curatively resectable. Resectability has to be defined by a surgeon
before radiochemotherapy. The tumor is considered unresectable due to T-stage,
N-stage, performance status, nutritional status, co-morbidity (pulmonal function,
other), tumor location upper third or other reasons

- Karnofsky Performance Status ≥ 70

- Women of child-bearing potential must have a negative pregnancy test

- Adequate cardial-, pulmonal- and ear function

Adequate bone marrow function:

- leukocytes ≥ 3.0 x 10^9/L

- neutrophiles ≥ 1.5 x 10^9/L

- thrombocytes ≥ 100 x 10^9/L

- hemoglobin ≥ 10.0 g/dl

Adequate liver function:

- bilirubin ≤ 2.0 mg/dl

- SGOT, SGPT, AP, gamma-GT ≤ 3 x ULN

Adequate kidney function:

- serum creatinine ≤ 1.5 mg/dl

- creatinine clearance ≥ 50 ml/min according to Cockcroft-Gault Formula

- no known allergies against chimeric antibodies

- effective contraception for male and female patients if there is a risk of conception

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Exclusion Criteria

- distant metastasis

- previous treatment of esophageal cancer

- previous therapy with monoclonal antibodies and / or EGFR-targeted therapy

- previous second malignancies with exception of a history of a previous curatively
treated basal cell carcinoma of the skin or pre-invasive cervix carcinoma

- serious concomitant disease or medical condition

- FEV1 < 1.1

- clinically relevant coronary artery diseases or known myocardial infarction within
the last 12 months or ventricular ejection fraction (LVEF) below normal

- every active dermatological condition > grade 1

- contraindications to receive cisplatin, 5-FU or cetuximab

- concurrent treatment with other experimental drugs or participation in another
clinical trial within 30 days before study start

- patient pregnant or breast feeding

- known drug abuse, medication abuse, alcohol abuse

- social situations limiting the compliance with the study requirements

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Addresses

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    • University of Schleswig-Holstein
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    • Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Strahlentherapie
    • Dirk Rades, Prof. Dr. 
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    • Dirk Rades, Prof. Dr. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.