Radiotherapy Treatments for Neoplasms in the Head and Neck Region

Head and Neck Neoplasms Clinical Trial

Official title:

Radiotherapy Treatments for Neoplasms in the Head and Neck Region

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06335342
• Other study ID #: IEO 0726
• Status: Recruiting
• Start date: February 22, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Barbara Alicja Jereczek
• Phone: +39 02 57489326
• Email: barbara.jereczek[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4050
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Signed informed consent

Exclusion Criteria:

1. Radiotherapy in districts other than the head and neck region

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Neoplasms

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Number of patients death	5 years
Primary	Disease free survival	Number of oncological event (local recurrence, distant metastasis, other primary tumor)	5 years