Skin Changes in Head and Neck Cancer During Immuno-(Chemo-) And Radiotherapy With Erbitux® (HICARE) (HICARE)
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|ClinicalTrials.gov Identifier: NCT01553032|
Recruitment Status : Unknown
Verified August 2013 by Prof. Dr. Juergen Debus, University of Heidelberg Medical Center.
Recruitment status was: Recruiting
First Posted : March 13, 2012
Last Update Posted : August 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Erbitux® Radiation: Fractionated Radiotherapy||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Skin Changes in Head and Neck Cancer During Immuno-(Chemo-) And Radiotherapy With Erbitux®|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||October 2013|
|Active Comparator: 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 Name: 3D-conventional or IMRT
- 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
- 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 ]
- Rate of cetuximab-mediated nail changes [ Time Frame: 2 years after LPI ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553032
|Contact: Victor Suarez, PhD||+4976115242 ext email@example.com|
|University of Heidelberg Medical Center||Recruiting|
|Germany, Baden-Württemberg, Germany, 69120|
|Contact: Karin M Potthoff, MD +496221568201 firstname.lastname@example.org|
|Contact: Gregor Habl, MD +496221568201 email@example.com|
|Principal Investigator: Jürgen Debus, Prof. Dr. Dr|
|Principal Investigator:||Jürgen Debus, Prof. Dr. Dr||University Heidelberg, Klinik für Radioonkologie und Strahlentherapie, Im Neuenheimer Feld 400, 69120 Heidelberg|