Outcome Prediction in Head&Neck Cancer Patients After Radiotherapy

Head and Neck Cancer Clinical Trial

— OutcomeH&N  

Official title:

Outcome Prediction in Head&Neck Cancer Patients After Radiotherapy Using Multi-parameter Modelling: Disease Control, Toxicity and Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01985984
• Other study ID #: 12-02-8/02-extern-6820
• Status: Recruiting
• Start date: July 2012
• Est. completion date: January 2030

Study information

• Verified date: October 2023
• Source: Maastricht Radiation Oncology
• Contact: F Hoebers, MD, PhD
• Phone: +31884455666
• Email: frank.hoebers[@]maastro.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All patients planned for curatively intended primary or postoperative radiotherapy

Exclusion Criteria:

All patients planned for palliative radiotherapy

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• Radiation alone
Radiation alone
• Radiation in combination with systemic therapy
Radiation in combination with systemic therapy

Locations

Country	Name	City	State
Netherlands	Maastro Clinic	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-rated symptoms and quality of life	quality of life (EORTC QLQ-C30, EORTC QLQ-H&N35, EuroQoL-EQ5D)	5 years
Other	Acute and late toxicity scores, according to CTCv4.0 criteria		5 years
Primary	overall survival	The overall survival will be calculated from the first day of treatment, either the first day of induction chemotherapy or the first day of radiotherapy in case of concomitant chemoradiation or radiation alone. An event is defined as death of any cause.	5 years
Secondary	disease free survival		5 years
Secondary	loco-regional control	Loco-regional control will be calculated from the first day of treatment, either the first day of induction chemotherapy or the first day of radiotherapy in case of concomitant chemoradiation or radiation alone. An event is defined as local recurrence and/or regional recurrence. These two events will be separately scored.	5 years