Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005529

Trial Description

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Title

Skin Changes in Head and Neck Cancer During Immuno-(Chemo-) And Radiotherapy With Erbitux®

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Trial Acronym

HICARE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This is a national multicenter phase IV study to assess acute radiation dermatitis of
combined radioimmuno(chemo)therapy with Cetuximab in patients with locally advanced,
non-metastatic squamous cell carcinoma of the head and neck (LASCCHN).

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Brief Summary in Scientific Language

With the aim of optimizing combined treatment strategies in terms of efficacy as well as
manageable side effects, the implementation of Cetuximab an EGFR targeting antibody
demonstrated successfully a significant increase in survival times, although exhibiting an
expected increase in skin toxicities (1,2). This Phase IV trial will explore this prominent
side effect, which is due to a synergistic effect of radiodermatitis and acneiform rash, in
great detail. In addition, feasibility aspects of the complex treatment schedule in common
routine and with patients presenting an increased comorbidity rate compared to the study
population studied in the pivotal Phase III trial will be observed.

Further, peripheral blood samples of patients that consent to participate in the molecular
monitoring will be collected and their genetic, epigenetic- and transcriptional profiles
correlated with clinical outcome parameters. The goal of this translational program is to
identify and confirm novel peripheral blood based molecular predictors and surrogates of
therapy response. Tissue samples and available medical evidence of patients that consent to
participate in the assessment of the HPV status will be collected. The goal of this program
is to correlate HPV status with clinical outcome parameters.

In addition, all patients will answer Quality of Life questionnaires including the EORTC
QLQ-C30 questionnaire, the Head and Neck cancer specific module (3) and the Dermatology Life
Quality Index (DLQI).

This prospective, open, multicenter phase IV study is designed to assess the rate of
radiodermatitis in patients with LASCCHN treated with a combination of radiotherapy and the
EGFR-targeted monoclonal antibody Cetuximab.

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Organizational Data

  •   DRKS00005529
  •   2014/03/07
  •   2011/05/31
  •   yes
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Secondary IDs

  •   2010-019748-38 
  •   NCT01553032  (ClinicalTrials.gov)
  •   UniHD-2010-11-40-1001  (University of Heidelberg Medical Center)
  •   2010-019748-38 
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Health Condition or Problem studied

  •   Head and Neck Cancer
  •   C01 -  Malignant neoplasm of base of tongue
  •   C02 -  Malignant neoplasm of other and unspecified parts of tongue
  •   C03 -  Malignant neoplasm of gum
  •   C04 -  Malignant neoplasm of floor of mouth
  •   C05 -  Malignant neoplasm of palate
  •   C06 -  Malignant neoplasm of other and unspecified parts of mouth
  •   C10 -  Malignant neoplasm of oropharynx
  •   C13 -  Malignant neoplasm of hypopharynx
  •   C32 -  Malignant neoplasm of larynx
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Interventions/Observational Groups

  •   Drug: Erbitux®
  •   Radiation: Fractionated Radiotherapy
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
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Primary Outcome

- Rate of radiation dermatitis Grade 3/4; time frame: 2 years after LPI; Criteria for Adverse Events v4.0 (CTCAE) Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-theatening consequences Grade 5: Death

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Secondary Outcome

- Rate of radiation dermatitis Grade1/2; time frame: 2 years after LPI; Criteria for Adverse Events v4.0 (CTCAE) Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-theatening consequences Grade 5: Death
- Rate of cetuximab-mediated acneiform rash Grade 1-4; time frame: 2 years after LPI; Criteria for Adverse Events v4.0 (CTCAE) Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-theatening consequences Grade 5: Death
- Rate of cetuximab-mediated rhagades; time frame: 2 years after LPI; Criteria for Adverse Events v4.0 (CTCAE) Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-theatening consequences Grade 5: Death
- Rate of cetuximab-mediated nail changes; time frame: 2 years after LPI; Criteria for Adverse Events v4.0 (CTCAE) Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-theatening consequences Grade 5: Death
- ORR; LRC; PFS; OS; time frame: 2 years after LPI; In %
- Safety profile; time frame: 2 years after LPI
- Median dose density of radiation; time frame: 2 years after LPI
- Safety profile of applied radiation protocol; time frame: 2 years after LPI

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2011/05/31
  •   500
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Inclusion Criteria

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

- Histologically confirmed, locally advanced (stage III, IVA or IVB) non-metastatic
squamous-cell carcinoma of the oral cavity, oro- or hypopharynx and larynx

- ECOG Performance Status of 0-2

- ≥ 18 years of age

- Life expectancy of at least 6 months.

- Adequate bone marrow, liver and renal function (according to SmPC of Cetuximab) based
on laboratory assessments raised within 7 days prior to start of study treatment.

- Signed and dated informed consent before the start of specific protocol procedures.

- Women of childbearing potential must have had a negative serum or urine beta-HCG
pregnancy test within 7 days prior to the first administration of study treatment or
must have a documented condition that prohibits pregnancy (e.g. post-menopausal;
hysterectomy).

- Patients enrolled in this trial must be willing to use effective birth control
measures during the course of the trial and the subsequent 2 months

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Exclusion Criteria

- Nasopharyngeal carcinoma

- Distant metastases

- Previous radiotherapy for carcinoma of the head and neck

- Participation in other clinical trial (according to the German Drug Law
(Arzneimittelgesetz - AMG) within 30 days prior to start of study treatment

- Previous exposure to epidermal growth factor (EGFR) targeted therapy

- Known hypersensitive reaction to any of the components of study treatments

- Previous or concurrent cancer within 5 years prior to study entry that is distinct in
primary site or histology except adequately treated basal cell carcinoma or
preinvasive cervical carcinoma.

- Pregnant or breast-feeding patients

- Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results as judged
by the investigator

- Any condition that is unstable or could jeopardise the safety of the patient and
their compliance in the study as judged by the investigator

- Incapacity to consent or limited legal capacity to consent

Note: A combination of the applied radioimmunotherapy with a chemotherapy in terms of a
Radioimmunochemotherapy (e.g. with Cisplatin or Carboplatin/5-Fluorouracil) is no
exclusion criteria. Furthermore, a patient previously treated with an induction
chemotherapy is allowed to participate in this trial.

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Addresses

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    • University of Heidelberg Medical Center
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    • iOMEDICO AG
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    •   [---]*
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    • University Heidelberg, Klinik für Radioonkologie und Strahlentherapie, Im Neuenheimer Feld 400, 69120 Heidelberg
    • Jürgen Debus, Prof. Dr. Dr 
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    • Victor Suarez, PhD 
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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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    •   [---]*
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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 .
  •   1
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.