About this trial
The primary and general objective of the clinical introduction of the Standard Follow-up Program (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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Characteristics of the population: * Patients with Head and Neck Cancer, treated with curative intent * Any tumor site * Stage I-IV, M0 * Treated with radiotherapy alone or in combination with systemic therapy * Definitive radiotherapy or postoperative radiotherapy
Trial design
Cohort
Prospective
Treatments tested in this trial
Radiation alone
RadiationRadiation alone
Radiation in combination with systemic therapy
RadiationRadiation in combination with systemic therapy
Treatment groups
Trial outcomes
Primary outcomes
overall survival
The overall survival will be calculated from the first day of treatment, either the first day of induction chemotherapy or the first day of radiotherapy in case of concomitant chemoradiation or radiation alone. An event is defined as death of any cause.
Secondary outcomes
disease free survival
loco-regional control
Loco-regional control will be calculated from the first day of treatment, either the first day of induction chemotherapy or the first day of radiotherapy in case of concomitant chemoradiation or radiation alone. An event is defined as local recurrence and/or regional recurrence. These two events will be separately scored.
Other outcomes
Patient-rated symptoms and quality of life
quality of life (EORTC QLQ-C30, EORTC QLQ-H\&N35, EuroQoL-EQ5D)
Acute and late toxicity scores, according to CTCv4.0 criteria
Sponsors and contacts
Click on the lead sponsor to view all of their trials.