Studies

Observational Recruiting

NCT06773039 on ClinicalTrials.gov

Assessment of Different Therapeutic Strategies in Patients With Head and Neck Neoplasms Treated With Radiotherapy

Official title: Assessment of Toxicity and Outcomes of Different Therapeutic Strategies in Patients With Head and Neck Neoplasms Treated With Radiotherapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna

  • Sponsor: Policlinico S.Orsola-Malpighi
  • Enrollment: 3000 (Estimated)
  • Study start: 2021-10-28 (Actual)
  • Primary completion: 2030-11-15 (Estimated)
  • Study completion: 2030-12-15 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

This is a monocentric observational study aimed at collecting data related to the radiotherapy treatment of head and neck neoplasms. The purpose of the study is to systematically gather data on radiotherapy for head and neck neoplasms to evaluate tumor response and potential toxicity in relation to dosages and techniques used, the combination with other therapies, disease characteristics, and the psychological impact of the proposed treatments.

Additionally, collecting data on both disease characteristics and pre-existing conditions in a large sample may allow for the assessment of any correlation with radiation-induced toxicities, with the goal of predicting and preventing them in a personalized manner in the future.

The study's aim is thus to evaluate tumor response and any potential toxicity following radiotherapy treatment concerning treatment modalities, dosages, and techniques used, for both new diagnoses and cases already diagnosed and treated since January 1, 2000, at the Radiotherapy Unit of the S. Orsola-Malpighi Polyclinic. The structured data collection necessary for evaluating the objectives will cover the observation period from January 1, 2000, to December 15, 2030, involving approximately 3,000 patients. Participation in the study solely involves the structured collection of certain information already present in your medical records, as well as data related to clinical exams, radiological imaging, and therapies, without any modifications to standard clinical practice. Participation in the study incurs no costs and will not be compensated in any way. There are no risks or inconveniences associated with participating in this study. Enrolled patients will not receive any direct benefit from this study, as it is purely a data collection effort. The collected data will enhance understanding of the factors associated with treatment outcomes, ultimately leading to improved management of each individual patient.

Conditions

  • Head and Neck Cancer

Primary Outcome Measures

  • Evaluate the correlation of therapy response (From enrollment to the last follow-up at 12 months)
    Evaluate the correlation of therapy response with other parameters in the radiotherapy treatment of head and neck neoplasms, considering the treatment setting, dosages, and techniques used

Countries

Italy

Locations and Investigators

Study Officials