Skin Changes in Head and Neck Cancer During Immuno-(Chemo-) And Radiotherapy With Erbitux® (HICARE)
HICARE
2 other identifiers
interventional
139
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 head-and-neck-cancer
Started Jun 2011
Longer than P75 for phase_4 head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedMay 25, 2022
May 1, 2022
5.9 years
May 31, 2011
May 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of radiation dermatitis Grade 3/4
Criteria for Adverse Events v4.0 (CTCAE) Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-theatening consequences Grade 5: Death
2 years after LPI
Secondary Outcomes (8)
Rate of radiation dermatitis Grade1/2
2 years after LPI
Rate of cetuximab-mediated acneiform rash Grade 1-4
2 years after LPI
Rate of cetuximab-mediated rhagades
2 years after LPI
Rate of cetuximab-mediated nail changes
2 years after LPI
ORR; LRC; PFS; OS
2 years after LPI
- +3 more secondary outcomes
Study Arms (2)
Erbitux®
ACTIVE COMPARATORFractionated Radiotherapy
ACTIVE COMPARATORInterventions
400mg/m2 initial dose, followed by weekly doses of 250mg/m2 Treatment duration: 7-8 weeks
30-35 fractions of radiotherapy (6-7 weeks)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Heidelberg Medical Centerlead
- iOMEDICO AGcollaborator
Study Sites (1)
University of Heidelberg Medical Center
Heidelberg, Baden-Wurttemberg, 69120, Germany
Related Publications (1)
Habl G, Potthoff K, Haefner MF, Abdollahi A, Hassel JC, Boller E, Indorf M, Debus J. Differentiation of irradiation and cetuximab induced skin reactions in patients with locally advanced head and neck cancer undergoing radioimmunotherapy: the HICARE protocol (head and neck cancer: immunochemo and radiotherapy with erbitux) - a multicenter phase IV trial. BMC Cancer. 2013 Jul 15;13:345. doi: 10.1186/1471-2407-13-345.
PMID: 23855804DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jürgen Debus, Prof. Dr. Dr
University Heidelberg, Klinik für Radioonkologie und Strahlentherapie, Im Neuenheimer Feld 400, 69120 Heidelberg
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Dr.
Study Record Dates
First Submitted
May 31, 2011
First Posted
March 13, 2012
Study Start
June 1, 2011
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
May 25, 2022
Record last verified: 2022-05