Clinical trial NCT02435576: Standard Follow-up Program (SFP) for Head and Neck Cancer Patients
Official title: Standard Follow-up Program (SFP) for Head and Neck Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation (SFP Head & Neck)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Keywords: Acute toxicity
Late toxicity
NTCP models
Proton therapy
Patient-rated outcomes
Quality of life
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 10000
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 with head and neck cancer planned for curatively intended primary or postoperative radiotherapy will be included.

Brief summary: 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Late toxicity
timeFrame: At 6 months after last day of completion of treatment
Secondary outcomes:
measure: Change in acute toxicity
timeFrame: At 1,2,3,4,5,6,7 (= during radiation therapy) and 12 weeks (= 6 weeks after completion of treatment) 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 completion of treatment
measure: Overall survival
timeFrame: At 1,2,3,4 and 5 years after completion of treatment
measure: Change in locoregional tumour control
timeFrame: At 1,2,3,4 and 5 years after completion of treatment
measure: Laryngo-oesophageal dysfunction-free survival
timeFrame: At 1,2,3,4 and 5 years after completion of treatment
measure: Change in patient-rated symptoms
timeFrame: At 1,2,3,4,5,6,7 (= during radiation therapy) and 12 weeks (= 6 weeks after completion of treatment) after first day of radiation therapy
measure: Late toxicity
timeFrame: At 12 months after last day of completion of treatment
measure: Late toxicity
timeFrame: At 18 months after last day of completion of treatment
measure: Late toxicity
timeFrame: At 24 months after last day of completion of treatment
measure: Late toxicity
timeFrame: At 36 months after last day of completion of treatment
measure: Late toxicity
timeFrame: At 48 months after last day of completion of treatment
measure: Late toxicity
timeFrame: At 60 months after last day of completion of treatment
measure: Thyroid Stimulating Hormone (TSH)
timeFrame: At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy.
measure: Free Thyroxine-4 (FT4)
timeFrame: At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy.
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: J.A. Langendijk, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: