Clinical trial NCT06335342: Radiotherapy Treatments for Neoplasms in the Head and Neck Region
Official title: Radiotherapy Treatments for Neoplasms in the Head and Neck Region
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Neoplasms
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 4050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at European Institute of Oncology with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the head and neck region

Brief summary: The aim of this study is the evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of radiotherapy treatments in the head and neck region.

Eligible patients undergoing radiotherapy for primary or secondary neoplasms localized in the head and neck anatomical region.

Detailed description: Approximately 60% of patients with neoplasms receive radiotherapy as part of their oncological treatment.

Various primary tumors as well as metastases of various origins can be localized in the head and neck anatomical region. Patients with such neoplastic localizations will therefore receive radiotherapy treatment possibly associated with other systemic or surgical treatments.

Treatment choice is usually established following multidisciplinary discussions, based on disease characteristics and stage, concurrent pathologies and pharmacological treatments, patient preferences, and functional aspects.

The collection of data related to radiotherapy plays a crucial role in understanding various clinical aspects of the treatment itself. The availability of data from an increasing number of patients will allow the identification of clinical situations or technical parameters of radiotherapy correlated with treatment tolerance and effectiveness, aiming to identify the best treatment for these oncological pathologies.

This project aims to collect data related to radiotherapy treatments for primary or secondary neoplasms of the head and neck region for scientific dissemination with the goal of establishing the basis for evaluating achieved results over time, and deriving from these elements useful for guiding the most effective treatment strategies and appropriate operational protocols.

Eligibility criteria: Inclusion Criteria:

* Patients treated with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the head and neck region include those with:

  * Primary bone tumors,
  * Primary soft tissue tumors,
  * Primary tumors of the cardio-circulatory system,
  * Primary tumors of the lymphatic system,
  * Primary tumors of the nervous system and skin,
  * Secondary metastases from various origins localized in that district.
* Signed informed consent

Exclusion Criteria:

• Radiotherapy in districts other than the head and neck region

Primary outcomes:
measure: Overall Survival
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Barbara Alicja Jereczek
role: PRINCIPAL_INVESTIGATOR
References: