Clinical trial NCT02489084: Predictive Models for Radiation-induced Side Effects in Head and Neck Cancer Based on Single Nucleotide Polymorphisms (SNP)
Official title: Predictive Models for Radiation-induced Side Effects in Head and Neck Cancer Based on Single Nucleotide Polymorphisms (SNP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Keywords: Head and Neck neoplasms
Genome-wide association study
Polymorphism, single nucleotide
Toxicity
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients ≥18 years still alive and treated since April 2007 for HNC at the department of Radiation Oncology of the UMCG, Groningen, the Netherlands

Brief summary: Background of the study:

Swallowing dysfunction and xerostomia are the most frequently reported radiation-induced side effects (RISE) after (chemo) radiation ((CH) RT) in head and neck cancer (HNC) patients and have a major impact on the general dimensions of quality of life (QoL). In radiation0oncology, normal tissue complication probability (NTCP) models based on dose-volume parameters being used to determine the risk of acute and late RISE. NTCP models containing genetic determinants of radiosensitivity, such as single nucleotide polymorphisms (SNPs), may improve model performance and thus enable more individualized radiotherapy. Information of the predictive value of SNPs or SNP signatures among patients with HNC is currently not available.

Objective of the study:

The main objective of this project will be to test the hypothesis that SNP profiles can improve the performance of predictive models for the most frequently reported late RISE, i.e. dysphagia, in HNC patients after curative (CH) RT. Secondary objectives will be improvement of NTCP models for HNC patients by adding SNP profiles predictive of (1) acute mucositis; (2) acute dysphagia; (3) salivary dysfunction; (4) acute xerostomia; (5) late xerostomia; (6) osteoradionecrosis; (7) hypothyroidism; (8) patient-rated HNC symptoms and ; (9) quality of life.


Eligibility criteria: Inclusion Criteria:

* Histological proven head and neck cancer
* Primary site in the oral cavity, oropharynx, hypopharynx, nasopharynx, paranasal sinuses, and/or salivary glands
* Treatment with curative intent with primary or postoperative radiotherapy either or not combined with systemic treatment
* Northern European ethnicity (ethnicity is a known confounder in SNP association studies)
* Willing and able to comply with the study prescriptions
* 18 years or older
* No prior radiation (in the head and neck area)
* Patients must have sufficient knowledge of the Dutch language to understand the meaning of the study as described in the patient information
* Have given written informed consent before patient registration

Exclusion Criteria:

* Prior radiotherapy

Primary outcomes:
measure: Change in acute toxicity
timeFrame: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy
measure: Change in late toxicity
timeFrame: At 6,12,18,24,36,48,60 months after last day of completion of treatment
measure: Change in patient-rated symptoms
timeFrame: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy
measure: Change in patient-rated Quality-of-Life
timeFrame: At 6,12,18,24,36,48,60 months after last day of completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: