Outcome Prediction in Head&Neck Cancer Patients After Radiotherapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaastricht Radiation Oncology

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Radiation alone

    Radiation

    Radiation alone

  • Radiation in combination with systemic therapy

    Radiation

    Radiation in combination with systemic therapy

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: H&N cancer patients2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years

Secondary outcomes

1

disease free survival

Time frame
5 years
2

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.

Time frame
5 years

Other outcomes

1

Patient-rated symptoms and quality of life

quality of life (EORTC QLQ-C30, EORTC QLQ-H\&N35, EuroQoL-EQ5D)

Time frame
5 years
2

Acute and late toxicity scores, according to CTCv4.0 criteria

Time frame
5 years

Sponsors and contacts

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