Radiotherapy Treatments for Neoplasms in the Head and Neck Region

Recruiting

• Conditions: Head and Neck Neoplasms

• Registration Number: NCT06335342
• Lead Sponsor: European Institute of Oncology

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.

Study Timeline

• Study Start: 2018-02-22
• Status Verified: 2024-03
• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-03-28
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4050

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	5 years	Number of patients death
Disease free survival	5 years	Number of oncological event (local recurrence, distant metastasis, other primary tumor)

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy