Head and Neck Cancer Clinical Trial
— HICAREOfficial title:
Skin Changes in Head and Neck Cancer During Immuno-(Chemo-) And Radiotherapy With Erbitux®
Verified date | May 2022 |
Source | University of Heidelberg Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 139 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | University of Heidelberg Medical Center | Heidelberg | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
University of Heidelberg Medical Center | iOMEDICO AG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Rate of radiation dermatitis Grade1/2 | 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 | Rate of cetuximab-mediated acneiform rash Grade 1-4 | 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 | Rate of cetuximab-mediated rhagades | 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 | Rate of cetuximab-mediated nail changes | 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 | ORR; LRC; PFS; OS | In % | 2 years after LPI | |
Secondary | Safety profile | 2 years after LPI | ||
Secondary | Median dose density of radiation | 2 years after LPI | ||
Secondary | Safety profile of applied radiation protocol | 2 years after LPI |
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