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NCT Number: NCT02103010

Predictive Modelling for Patient Stratification According to Treatment-related Toxicity and Survival After Chemoradiation for Head and Neck Cancer

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Radiotherapy, University Hospital Ghent, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in dysphagia

    Time frame: during radiotherapy and at 6/12/18/24 months after the end of radiotherapy

    Dysphagia during radiotherapy and at 6/12/18/24 months after the end of radiotherapy using the CTCAE (Common Terminology Criteria for Adverse Events) v4.0 scale.

  2. change in xerostomia

    Time frame: during radiotherapy and at 6/12/18/24 months after the end of radiotherapy

    xerostomia during radiotherapy and at 6/12/18/24 months after the end of radiotherapy using the CTCAE (Common Terminology Criteria for Adverse Events) v4.0 scale

  3. change in overall survival

    Time frame: up to three years after study start

  4. change in disease specific survival

    Time frame: up to three years after study start

  5. change in progression-free survival

    Time frame: up to three years after study start

  6. appearance of distant metastasis

    Time frame: up to three years after study start

Secondary outcomes

  1. Change in weight loss

    Time frame: during radiotherapy and at 6/12/18/24 months after the end of radiotherapy

  2. change of Quality of life

    Time frame: pre-radiotherapy, at the last day of radiotherapy and post-radiotherapy (12/24 months)

    using the EORTC (European Organisation for Research and Treatment of Cancer ) quality of life questionnaire C30 and the hand and neck cancer specific quality of life questionnaire HN35

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Centre Oscar Lambret
  • Maastro Clinic, The Netherlands
  • Universitaire Ziekenhuizen KU Leuven
  • University Ghent

Registry information

Acronym: PRETOXIS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 3, 2014
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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