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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Heidelberg Medical Center
Sponsor:
Collaborator:
iOMEDICO AG
Information provided by (Responsible Party):
Prof. Dr. Juergen Debus, University of Heidelberg Medical Center
ClinicalTrials.gov Identifier:
NCT01553032
First received: May 31, 2011
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention Phase
Head and Neck Cancer
Drug: Erbitux®
Radiation: Fractionated Radiotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Skin Changes in Head and Neck Cancer During Immuno-(Chemo-) And Radiotherapy With Erbitux®

Resource links provided by NLM:


Further study details as provided by University of Heidelberg Medical Center:

Primary Outcome Measures:
  • Rate of radiation dermatitis Grade 3/4 [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
    Criteria for Adverse Events v4.0 (CTCAE) Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-theatening consequences Grade 5: Death


Secondary Outcome Measures:
  • Rate of radiation dermatitis Grade1/2 [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    In %

  • Safety profile [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
  • Median dose density of radiation [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
  • Safety profile of applied radiation protocol [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: May 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Erbitux® Drug: Erbitux®
400mg/m2 initial dose, followed by weekly doses of 250mg/m2 Treatment duration: 7-8 weeks
Active Comparator: Fractionated Radiotherapy Radiation: Fractionated Radiotherapy
30-35 fractions of radiotherapy (6-7 weeks)
Other Names:
  • Fractionated Radiotherapy
  • 3D-conventional or IMRT

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553032

Contacts
Contact: Victor Suarez, PhD +4976115242 ext 62 info@iomedico.com

Locations
Germany
University of Heidelberg Medical Center Recruiting
Germany, Baden-Württemberg, Germany, 69120
Contact: Karin M Potthoff, MD    +496221568201    karin.potthoff@med.uni-heidelberg.de   
Contact: Gregor Habl, MD    +496221568201    gregor.habl@med.uni-heidelberg.de   
Principal Investigator: Jürgen Debus, Prof. Dr. Dr         
Sponsors and Collaborators
University of Heidelberg Medical Center
iOMEDICO AG
Investigators
Principal Investigator: Jürgen Debus, Prof. Dr. Dr University Heidelberg, Klinik für Radioonkologie und Strahlentherapie, Im Neuenheimer Feld 400, 69120 Heidelberg
  More Information

No publications provided by University of Heidelberg Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Juergen Debus, Prof. Dr. Dr., University of Heidelberg Medical Center
ClinicalTrials.gov Identifier: NCT01553032     History of Changes
Other Study ID Numbers: UniHD-2010-11-40-1001, 2010-019748-38
Study First Received: May 31, 2011
Last Updated: August 1, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by University of Heidelberg Medical Center:
Immuno-(Chemo-)and Radiotherapy
Erbitux®
Skin changes in Head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Cetuximab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014