Outcome Prediction in Head&Neck Cancer Patients After Radiotherapy (OutcomeH&N)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Radiation: Radiation alone; Radiation: Radiation in combination with systemic therapy

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: F Hoebers, MD, PhD; Phone Number: +31884455666; Email: frank.hoebers@maastro.nl

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Recruiting
    • Maastro clinic
    • Contact: Ph Lambin, prof Dr
    • Principal Investigator: Frank Hoebers, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Characteristics of the population:

• 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

Description

Inclusion Criteria:

All patients planned for curatively intended primary or postoperative radiotherapy

Exclusion Criteria:

All patients planned for palliative radiotherapy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: Radiation alone; Radiation alone; Radiation: Radiation in combination with systemic therapy; Radiation in combination with systemic therapy; Other Names: Chemoradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease free survival		5 years
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-rated symptoms and quality of life	quality of life (EORTC QLQ-C30, EORTC QLQ-H&N35, EuroQoL-EQ5D)	5 years
Acute and late toxicity scores, according to CTCv4.0 criteria		5 years

Collaborators and Investigators

• Sponsor: Maastricht Radiation Oncology
• Investigators: Principal Investigator: F Hoebers, MD, PhD, Maastro Clinic, The Netherlands

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: November 15, 2013
• First Posted (Estimated): November 18, 2013

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Head and neck cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 12-02-8/02-extern-6820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO