Outcome Prediction in Head&Neck Cancer Patients After Radiotherapy

NCT ID: NCT01985984

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2030-01-31

Brief Summary

The primary and general objective of the clinical introduction of the Standard Follow-up Program (SFP) as the current standard of care is to improve the quality of radiotherapy for head and neck cancer patients by reducing radiation-induced side effects without hampering treatment efficacy in terms of locoregional tumour control and overall survival and to systematically evaluate the beneficial effect of newly introduced radiation technology for this particular group of patients. The clinical introduction of the SFP will allow for a systematic and broad scale quality improvement cycle for head and neck cancer patients treated with radiotherapy. In fact, this methodology can be considered a kind of quality circle for the clinical introduction of new radiation techniques, aiming at continuous efforts for further improvement.

Detailed Description

For head and neck squamous cell carcinoma (HNSCC), radiation therapy is one of the mainstays of therapy either as definitive therapy alone or in combination with systemic therapy or following surgical resection as postoperative treatment. Nowadays there's great attention for personalized medicine which aims at offering a patient the treatment that best suits the individual patient and its tumor characteristics. To apply personalized therapy, we need accurate outcome prediction models for disease control, treatment related toxicity and quality of life.

The main factors used for predictive/prognostic nomograms are clinical factors, like patient-, tumor- and treatment related factors (1). Standard examples of these include age, gender, co-morbidity, smoking history, hemoglobin levels, tumor site, TNM stage, tumor volume, HPV-status, and others. For larynx cancer the nomogram was made publicly available on www.predictcancer.org.

However, we anticipate that other factors will contribute to the (improvement of) prediction models. These factors may include genomic analysis of tumor specimens, quantitative image analysis (radiomics), blood biomarkers, and/or tumor-tissue markers (2).

In addition, treatment-related parameters also need to be considered and these not only include factors like overall treatment time, use of systemic therapy, prescribed radiation dose and fraction dose. With new techniques using EPID dosimetry, it is now possible to measure the delivered radiation dose and compare this to the prescribed dose (3,4). This offers the potential to apply Dose Guide RadioTherapy (DGRT), which especially in HNSCC may have a large impact, because anatomical changes during fractionated therapy are known to occur and lead to dose changes to targets and organs at risk (5,6).

The final objective of this study is to integrate all potential prognostic factors and develop reliable nomograms both for tumor control as well as complications.

Conditions

Head and Neck Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

H&N cancer patients

Patients with Head and Neck Cancer, treated with curative intent

• Any tumor site
• Stage I-IV, M0
• Treated with radiotherapy alone or in combination with systemic therapy
• Definitive radiotherapy or postoperative radiotherapy

Interventions:

• Radiation alone
• Radiation in combination with systemic therapy

Radiation alone

Intervention Type: RADIATION

Radiation alone

Radiation in combination with systemic therapy

Intervention Type: RADIATION

Radiation in combination with systemic therapy

Interventions

Radiation alone

Radiation alone

Intervention Type: RADIATION

Radiation in combination with systemic therapy

Radiation in combination with systemic therapy

Intervention Type: RADIATION

Other Intervention Names

Chemoradiation

Eligibility Criteria

Inclusion Criteria

All patients planned for curatively intended primary or postoperative radiotherapy

Exclusion Criteria

All patients planned for palliative radiotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht Radiation Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

F Hoebers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastro Clinic, The Netherlands

Locations

Maastro Clinic

Maastricht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

F Hoebers, MD, PhD

Role: CONTACT

frank.hoebers@maastro.nl

+31884455666

Facility Contacts

Ph Lambin, prof Dr

Role: primary

Other Identifiers

12-02-8/02-extern-6820

Identifier Type: -

Identifier Source: org_study_id