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Head and Neck CancerPhase 4HICARENCT01553032

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

A Phase 4 study testing Erbitux® and Fractionated Radiotherapy in people with Head and Neck Cancer, run by University of Heidelberg Medical Center at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Erbitux® and Fractionated Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
1 siteGermany
Study dates
Jun 2011to May 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University of Heidelberg Medical Center

    Heidelberg, Baden-Wurttemberg, 69120

Other trials in Germany

About this study

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

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).

Read the 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.

Being tested
Erbitux®, Fractionated Radiotherapy
Keywords
Immuno-(Chemo-)and Radiotherapy, Erbitux®, Skin changes in Head and neck cancer
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erbitux®Drug

    400mg/m2 initial dose, followed by weekly doses of 250mg/m2 Treatment duration: 7-8 weeks

  • Fractionated RadiotherapyRadiation

    Also called 3D-conventional or IMRT

    30-35 fractions of radiotherapy (6-7 weeks)

Study groups in NCT01553032
Study groupRoleWhat they receive
Erbitux®Active comparatorNot described
Receives: Drug: Erbitux®
Fractionated RadiotherapyActive comparatorNot described
Receives: Radiation: Fractionated Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years after LPI

Secondary outcomes (8)

  1. 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

    Measured: 2 years after LPI

  2. 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

    Measured: 2 years after LPI

  3. 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

    Measured: 2 years after LPI

  4. 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

    Measured: 2 years after LPI

  5. ORR; LRC; PFS; OS

    In %

    Measured: 2 years after LPI

  6. Safety profile

    Measured: 2 years after LPI

  7. Median dose density of radiation

    Measured: 2 years after LPI

  8. Safety profile of applied radiation protocol

    Measured: 2 years after LPI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2012 (estimated)
  2. Study startJun 2011
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01553032
Sponsor's protocol ID
UniHD-2010-11-40-1001
Other IDs
2010-019748-38
Acronym
HICARE
Status last verified
May 2022
First submitted
31 May 2011
Last updated
25 May 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23855804

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Erbitux® and Fractionated Radiotherapy in people with Head and Neck Cancer, run by University of Heidelberg Medical Center at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of radiation dermatitis Grade 3/4 (time frame: 2 years after LPI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01553032, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.

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