Radiotherapy of Head and Neck Cancer With SIB

NCT06831903 | Recruiting

• 1 other identifier: 159/16-sc
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Quality of Life (QOL); Head and Neck Cancer; Radiotherapy Side Effect; Radiotherapy, Conformal (IMRT)

Outcome Measures

Primary Outcomes (2)

• Local control rate.

  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.

  From the date of treatment initiation until local recurrence or last follow-up, whichever occurs first, assessed up to 60 months.

• Regional tumor control rate

  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

  From the date of treatment initiation until regional recurrence or last follow-up, whichever occurs first, assessed up to 60 months.

Secondary Outcomes (8)

• Overall Survival (OS)

  From the date of treatment initiation until death from any cause or last follow-up, whichever occurs first, assessed up to 60 months.

• Disease-Specific Survival (DSS)

  From the date of treatment initiation until disease-specific death or last follow-up, whichever occurs first, assessed up to 60 months.

• Metastasis-Free Survival (MFS)

  From the date of treatment initiation until the first occurrence of distant metastasis, death from any cause, or last follow-up, whichever occurs first, assessed up to 60 months.

• Secondary malignancies

  From Enrollment to the 5 years after the end of treatment.

• Toxicities

  From the date of enrollment until the occurrence of acute or late therapy-related toxicities, death, or last follow-up, whichever occurs first, assessed up to 60 months.

Study Arms (1)

Head and neck radio(chemo)therapy

Patients aged 18 and older with histologically confirmed malignant head and neck tumors, undergoing definitive or adjuvant radio(chemo)therapy at the University Hospital Würzburg between October 2019 and October 2034.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 18 and older with histologically confirmed malignant head and neck tumors, undergoing definitive or adjuvant radio(chemo)therapy at the University Hospital Würzburg between October 2019 and October 2034

You may qualify if:

• Patients aged 18 and older with histologically confirmed malignant head and neck tumors, undergoing definitive or adjuvant radio(chemo)therapy at the University Hospital Würzburg

You may not qualify if:

• missing informed consent
• mental or physical disorders leading to inability to understand and/or fill the quationary
• judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

University Clinic of Wuerzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Wounds and Injuries

Study Officials

• Victor Lewitzki, MD, PhD

  University Clinic of Wuerzburg, Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Lewitzki, MD, PhD

CONTACT

+49-931-201-28869; lewitzki_v@ukw.de

Sterk Vanessa

CONTACT

+49-931-201-28180; sterk_v@ukw.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: February 18, 2025
• Study Start: May 21, 2019
• Primary Completion (Estimated): October 1, 2034
• Study Completion (Estimated): October 1, 2039
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)