Clinical trial NCT02103010: Predictive Modelling for Patient Stratification According to Treatment-related Toxicity and Survival After Chemoradiation for Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Universitaire Ziekenhuizen KU Leuven
name: Maastro Clinic, The Netherlands
name: Centre Oscar Lambret
First posted: 2014-04-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with head and neck cancer

Brief summary: Radiotherapy is an integral component of the current multimodality treatment approach in locally advanced head and neck cancer (HNC). There is growing evidence that more aggressive treatment regimens improve tumour control and survival. However, intensified treatment is at the expense of increased toxicity, in particular severe acute mucositis. In addition and of increasing importance, late and irreversible treatment-related side effects, including xerostomia and swallowing dysfunction, occur in a considerable proportion of patients and negatively affect quality of life.

High-risk human papilloma virus (HPV), specifically HPV type-16, is implicated as the causative factor in a proportion of HNC, especially those of the oropharynx. HPV-related cancers respond well to chemoradiotherapy compared to HNC related to tobacco and alcohol. Furthermore, the incidence of HPV-related oropharyngeal cancer is rising in Western countries. Given the significant toxicity associated with concurrent chemoradiotherapy, subsets of patients could be managed differently.

The first objective of the project is to develop predictive models for radiation-induced dysphagia and xerostomia in HNC patients. Clinical characteristics, treatment parameters, dose-volume effects on healthy tissues and whole-genome genetic data will be considered. The second objective of the project is to study the prognostic value of HPV status together with a panel of tumour biomarkers in oropharyngeal cancer patients. The overall aim of the project is to stratify patients according to the risks (side-effects) and benefits (survival) of cancer treatment using the developed risk models. Clustering patients into different risk categories may aid treatment decision making reducing therapy toxicity without compromising survival.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx and larynx. Histologically confirmed cervical lymph node metastases of unknown primary cancer (CUP). For prognosis part of the study: only histologically confirmed squamous cell carcinoma of the oropharynx

  * Stages : Tany N1-3, T3-4 N0, T1-2 N0, if prophylactic neck irradiation is performed
  * Multidisciplinary decision of curative radiotherapy or radiochemotherapy
  * Karnofsky performance status ≥ 70%
  * Age ≥ 18 years old
  * Gender : male - female
  * Informed consent obtained, signed and dated before start of radiotherapy

Exclusion Criteria:

* Treatment combined with brachytherapy
* Treatment combined with cetuximab or other targeted agents
* Prior irradiation to the head and neck region
* History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease at least 5 years
* Distant metastases
* Pregnant or lactating women
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
* Patients unlikely to comply with the protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study

Primary outcomes:
measure: Change in dysphagia
timeFrame: during radiotherapy and at 6/12/18/24 months after the end of radiotherapy
measure: change in xerostomia
timeFrame: during radiotherapy and at 6/12/18/24 months after the end of radiotherapy
measure: change in overall survival
timeFrame: up to three years after study start
measure: change in disease specific survival
timeFrame: up to three years after study start
measure: change in progression-free survival
timeFrame: up to three years after study start
measure: appearance of distant metastasis
timeFrame: up to three years after study start
Secondary outcomes:
measure: Change in weight loss
timeFrame: during radiotherapy and at 6/12/18/24 months after the end of radiotherapy
measure: change of Quality of life
timeFrame: pre-radiotherapy, at the last day of radiotherapy and post-radiotherapy (12/24 months)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Radiotherapy, University Hospital Ghent
city: Leuven
country: Belgium
facility: Department of Radiotherapy, University Hospital Leuven
Study officials:
affiliation: Ghent University - Department of Basic Medical Sciences
name: Kim De Ruyck, Dr.
role: PRINCIPAL_INVESTIGATOR
References: