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

Head and Neck Cancer Clinical Trial

— PRETOXIS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103010
• Other study ID #: 2013/895
• Status: Completed
• Phase: N/A
• First received: March 31, 2014
• Last updated: April 21, 2017
• Start date: January 2014
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Locations

Country	Name	City	State
Belgium	Department of Radiotherapy, University Hospital Ghent	Ghent
Belgium	Department of Radiotherapy, University Hospital Leuven	Leuven

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Ghent	Centre Oscar Lambret, Maastro Clinic, The Netherlands, Universitaire Ziekenhuizen Leuven, University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dysphagia	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.	during radiotherapy and at 6/12/18/24 months after the end of radiotherapy
Primary	change in xerostomia	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	during radiotherapy and at 6/12/18/24 months after the end of radiotherapy
Primary	change in overall survival		up to three years after study start
Primary	change in disease specific survival		up to three years after study start
Primary	change in progression-free survival		up to three years after study start
Primary	appearance of distant metastasis		up to three years after study start
Secondary	Change in weight loss		during radiotherapy and at 6/12/18/24 months after the end of radiotherapy
Secondary	change of Quality of life	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	pre-radiotherapy, at the last day of radiotherapy and post-radiotherapy (12/24 months)