Standard Follow-up Program (SFP) for Head and Neck Cancer Patients (H&NTOX)

University Medical Center Groningen (UMCG)

Status: Enrolling

Conditions: Head and Neck Cancer

Treatments: Radiation: Radiotherapy (primary or postoperative)

Study type: Observational

Funder types: Other

Identifiers

NCT02435576

SFP2007-03

Details and patient eligibility

About

The primary and general objective of the clinical introduction of the SFP as the current standard of care is to improve the quality of radiotherapy for head and neck cancer patients by reducing radiation-induced side effects without hampering treatment efficacy in terms of locoregional tumour control and overall survival and to systematically evaluate the beneficial effect of newly introduced radiation technology for this particular group of patients. The clinical introduction of the SFP will allow for a systematic and broad scale quality improvement cycle for head and neck cancer patients treated with radiotherapy. In fact, this methodology can be considered a kind of quality circle for the clinical introduction of new radiation techniques, aiming at continuous efforts for further improvement.

Full description

Specific objectives

• To develop, validate, and improve normal tissue complication probability (NTCP) models for a wide variety of acute and late radiation-induced side effects relevant for head and neck cancer patients (step 1);
• To use the outcome of the NTCP models to better inform patients on the risks on acute and late toxicity;
• To use the outcome of the NTCP models for the definition of dose constraints for radiotherapy treatment planning in current practice;
• To use the outcome of the NTCP models for the development and investigation of the potential benefit of new and emerging radiation delivery technique, such as swallowing sparing intensity modulation radiation therapy (IMRT) and proton radiotherapy.
• To compare the outcome of new radiation delivery techniques that are clinically introduced with the current standard in terms of radiation-induced toxicity, patient-rated symptoms and quality of life and in terms of locoregional tumour control and overall survival

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients planned for curatively intended primary or postoperative radiotherapy will be included. At the first visit, patients are informed about the standard follow up program by the treating physician.

Exclusion criteria

• All patients planned for palliative radiotherapy will not be included in the SFP.