search
Back to results

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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Erbitux®
Fractionated Radiotherapy
Sponsored by
University of Heidelberg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Immuno-(Chemo-)and Radiotherapy, Erbitux®, Skin changes in Head and neck cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Heidelberg Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Erbitux®

Fractionated Radiotherapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
ORR; LRC; PFS; OS
In %
Safety profile
Median dose density of radiation
Safety profile of applied radiation protocol

Full Information

First Posted
May 31, 2011
Last Updated
May 18, 2022
Sponsor
University of Heidelberg Medical Center
Collaborators
iOMEDICO AG
search

1. Study Identification

Unique Protocol Identification Number
NCT01553032
Brief Title
Skin Changes in Head and Neck Cancer During Immuno-(Chemo-) And Radiotherapy With Erbitux® (HICARE)
Acronym
HICARE
Official Title
Skin Changes in Head and Neck Cancer During Immuno-(Chemo-) And Radiotherapy With Erbitux®
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Heidelberg Medical Center
Collaborators
iOMEDICO AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Immuno-(Chemo-)and Radiotherapy, Erbitux®, Skin changes in Head and neck cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erbitux®
Arm Type
Active Comparator
Arm Title
Fractionated Radiotherapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Erbitux®
Intervention Description
400mg/m2 initial dose, followed by weekly doses of 250mg/m2 Treatment duration: 7-8 weeks
Intervention Type
Radiation
Intervention Name(s)
Fractionated Radiotherapy
Other Intervention Name(s)
3D-conventional or IMRT
Intervention Description
30-35 fractions of radiotherapy (6-7 weeks)
Primary Outcome Measure Information:
Title
Rate of radiation dermatitis Grade 3/4
Description
Criteria for Adverse Events v4.0 (CTCAE) Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-theatening consequences Grade 5: Death
Time Frame
2 years after LPI
Secondary Outcome Measure Information:
Title
Rate of radiation dermatitis Grade1/2
Description
Criteria for Adverse Events v4.0 (CTCAE) Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-theatening consequences Grade 5: Death
Time Frame
2 years after LPI
Title
Rate of cetuximab-mediated acneiform rash Grade 1-4
Description
Criteria for Adverse Events v4.0 (CTCAE) Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-theatening consequences Grade 5: Death
Time Frame
2 years after LPI
Title
Rate of cetuximab-mediated rhagades
Description
Criteria for Adverse Events v4.0 (CTCAE) Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-theatening consequences Grade 5: Death
Time Frame
2 years after LPI
Title
Rate of cetuximab-mediated nail changes
Description
Criteria for Adverse Events v4.0 (CTCAE) Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-theatening consequences Grade 5: Death
Time Frame
2 years after LPI
Title
ORR; LRC; PFS; OS
Description
In %
Time Frame
2 years after LPI
Title
Safety profile
Time Frame
2 years after LPI
Title
Median dose density of radiation
Time Frame
2 years after LPI
Title
Safety profile of applied radiation protocol
Time Frame
2 years after LPI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Debus, Prof. Dr. Dr
Organizational Affiliation
University Heidelberg, Klinik für Radioonkologie und Strahlentherapie, Im Neuenheimer Feld 400, 69120 Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Heidelberg Medical Center
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23855804
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs