Radiotherapy of Head and Neck Cancer With SIB

Condition(s) studied

Study summary

Title: Simultaneous Integrated Boost in Primary and Adjuvant Therapy of Head and Neck Tumors: Quality Control Registry Prospective Longitudinal Observational Study

Short Title: Radiotherapy for Head and Neck Tumors with SIB

Objective: To evaluate the efficacy and safety of definitive and adjuvant radio(chemo)therapy with simultaneous integrated boost (SIB) in patients with head and neck cancers. The study aims to assess local and regional control, overall survival, metastasis-free survival, therapy-related toxicities, and quality of life.

Study Design: A prospective, longitudinal, non-interventional registry study documenting real-world outcomes and quality measures of therapy applied according to existing clinical guidelines.

Eligibility

Primary outcome measure(s)

• Local control rate. — From the date of treatment initiation until local recurrence or last follow-up, whichever occurs first, assessed up to 60 months.
  Key aspects of local tumor control include: No Evidence of Tumor Growth: The absence of measurable or observable increase in the size of the tumor at the primary site. Tumor Response to Treatment: Complete Response (CR): Disappearance of all signs of cancer at the primary site. Partial Response (PR): Reduction in tumor size without complete disappearance. Persistence of Stable Disease: The tumor remains unchanged in size and does not spread locally beyond the treated area. Time Frame: 5 years from treatment start. Assessment Methods: Clinical Examination: Evaluation of the treated site for physical signs of recurrence. Imaging Techniques: CT, MRI, or PET scans to detect residual or recurrent disease. Biopsy: When clinically indicated, to confirm recurrence if suspected.
• Regional tumor control rate — From the date of treatment initiation until regional recurrence or last follow-up, whichever occurs first, assessed up to 60 months.
  Key aspects of regional tumor control include: Absence of Disease Progression: No enlargement, growth, or new involvement of lymph nodes in the regional drainage area. Response to Treatment: Complete Response (CR): All detectable cancer in the regional lymph nodes has disappeared. Partial Response (PR): A significant reduction in the size of affected lymph nodes or nodal masses. Stable Disease: The size and characteristics of the regional lymph nodes remain unchanged after treatment, without evidence of further spread. Time Frame: 5 years Assessment Methods: Imaging: CT, MRI, or PET scans are used to assess lymph node involvement and detect residual or recurrent disease. Physical Examination: Palpation or clinical inspection for lymph node abnormalities. Biopsy or Fine Needle Aspiration: To confirm suspected recurrence or residual

Trial sites (1)

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