Radiotherapy Treatments for Neoplasms in the Head and Neck Region

NCT ID: NCT06335342

Last Updated: 2024-08-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 4050 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2024-12-31

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.

Conditions

Head and Neck Neoplasms

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Radiotherapy to head and neck region

Patients treated at European Institute of Oncology with radiotherapy to head and neck region

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Alicja Jereczek

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

European Institute of Oncology

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Barbara Alicja Jereczek

Role: CONTACT

barbara.jereczek@ieo.it

+39 02 57489326

Facility Contacts

Barbara Alicja Jereczek

Role: primary

Other Identifiers

IEO 0726

Identifier Type: -

Identifier Source: org_study_id