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

NCT02103010 | Completed

• 1 other identifier: 2013/895
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• change in overall survival

  up to three years after study start

• change in disease specific survival

  up to three years after study start

• change in progression-free survival

  up to three years after study start

• appearance of distant metastasis

  up to three years after study start

Secondary Outcomes (2)

• Change in weight loss

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

• change of Quality of life

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

Study Arms (1)

HNC patients

head and neck cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with head and neck cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Maastro Clinic, The Netherlands: collaborator
• Centre Oscar Lambret: collaborator

Study Sites (2)

Department of Radiotherapy, University Hospital Ghent

Ghent, Belgium

Location

Department of Radiotherapy, University Hospital Leuven

Leuven, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Kim De Ruyck, Dr.

  Ghent University - Department of Basic Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 3, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 24, 2017

Record last verified: 2017-04

Locations

BE (2)