Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Noch nicht rekrutierend

NCT-Nummer:
NCT06380686

Studienbeginn:
Mai 2024

Letztes Update:
24.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
AIO-Studien-gGmbH

Collaborator:
Merck Sharp & Dohme LLC

Studienleiter

Victor Grünwald, Prof. Dr.
Principal Investigator
Universitätsklinikum Essen

Kontakt

Project Manager
Kontakt:
Phone: +49 (0)30 814534431
E-Mail: acticca-2@aio-studien-ggmbh.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Kinderonkologisches Zentrum Universitätsklinikum Essen
Hufelandstraße 55
45147 Essen
Deutschland» Google-Maps
Ansprechpartner:
Victor Grünwald, Prof. Dr.
Phone: +49 201 723 85584
E-Mail: viktor.gruenwald@uk-essen.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

The advent of checkpoint inhibitors has changed the treatment landscape in SCCHN and new

treatment sequences have entered clinical practice.

More in-depth knowledge of tumor biomarkers are important measures for optimization of

treatment strategies in SCCHN. In addition to this, investigations may involve other

assessments, which will be explored separately, such as molecular testing. These tests are

then linked to the core data set and will allow to associate such measures with outcomes.

This concept is flexible and allows for rapid integration of contemporary research questions

in a timely manner.

Furthermore, insights into the treatment reality for recurrent/metastatic salivary gland

carcinoma and other rare tumor entities (SNUC, etc.) are urgently needed, as there is

currently no established standard of care.

The monoclonal antibody cetuximab in combination with platinum and fluorouracil (EXTREME) has

been the standard of care for recurrent or metastatic (r/m) SCCHN for over a decade.1

Recently, the immune checkpoint inhibitors (CPIs) nivolumab and pembrolizumab have changed

the therapeutic landscape of patients with r/m SCCHN. Nivolumab is considered as therapeutic

standard after failure of platinum-based therapy based on the results of the phase III

Checkmate-141 trial.2 In addition, pembrolizumab has become the new standard in the

first-line setting in combination with platinum/fluorouracil chemotherapy or as monotherapy

for patients with programmed cell death ligand 1 (PD-L1) positive tumors based on the data

from the phase III Keynote-048 trial.3 Moreover, cetuximab in combination with platinum and

docetaxel (TPEx) has emerged as a less toxic alternative to the EXTREME regimen.4 Due to the

shifting first-line treatment landscape, data to guide contemporary 2nd line therapy are

scarce and the optimal treatment sequence remains vague.2,5,6 The implementation of

biomarkers and selection of patients in a real-world setting are areas of academic interest.

In addition, the assessment of treatment outcomes in rare entities are underrepresented in

pivotal trials, and as a matter of fact, may be completely excluded. However, broad labels

permit the use of novel agents, but a larger body of evidence is needed to substantiate such

treatment choices. HEAT seeks to address these questions by inclusion of a real-world patient

population and continuous assessment of oncological outcomes by means of a core clinical data

set implemented into HEAT.

Overall, HEAT is a study platform, which continuously assesses clinical outcomes and

modularly integrates additional measures to enable rapid answers to research questions.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age ≥ 18 years

- Able to understand and willing to sign written informed consent

- Histologically or cytologically confirmed epithelial or undifferentiated malignancy of

the head and neck area (except malignancy of the thyroid gland, malignant melanoma of

the skin or basal cell carcinoma of the skin), including, but not limited to:

- Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx

- Patients not amenable for curative treatment who receive palliative systemic treatment

or best supportive care

- Informed consent no later than four weeks after start of first-line palliative

systemic treatment. For patients receiving "best supportive care only": no later than

six weeks after diagnosis/recurrence or metastatic disease

Exclusion Criteria:

- Malignancy of the thyroid gland

- Malignant melanoma of the skin

- Basal cell carcinoma of the skin

- Soft tissue sarcoma of the head and neck region

Studien-Rationale

Primary outcome:

1. Sociodemographic factors (Time Frame - 3 years):
Highest level of education, Employment status, Current professional activity, Professional risk factors, Level of self-sufficiency, Care degree

2. Treatments (Time Frame - 3 years):
Types of local therapies (surgery, radiotherapy, radiochemotherapy), systemic therapy and therapeutic sequences

3. Response rates (Time Frame - 3 years):
Response rates

4. Treatment decision (Time Frame - 3 years):
Physician-reported parameters affecting treatment decision

5. Progression-free survival (Time Frame - 3 years):
Progression-free survival

6. Time-to-treatment-failure (Time Frame - 3 years):
Time-to-treatment-failure

7. Overall survival (Time Frame - 3 years):
Overall survival

Geprüfte Regime

data collection:
Demography, Social history, Riskfactors, Relevant medical history, Oncological family history, Disease & treatment history, Molecular Pathology and Results, Treatment data, Response data, progession free survial, overall survival.

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!