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

Head and Neck Cancer Clinical Trial

— H&NTOX  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02435576
• Other study ID #: SFP2007-03
• Status: Recruiting
• Start date: March 2007
• Est. completion date: January 2028

Study information

• Verified date: April 2024
• Source: University Medical Center Groningen
• Contact: J.A. Langendijk, Prof. Dr.
• Phone: +31503615532
• Email: j.a.langendijk[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 2028
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• Radiotherapy (primary or postoperative)

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late toxicity	Late toxicity	At 6 months after last day of completion of treatment
Secondary	Change in acute toxicity	Change in acute toxicity	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
Secondary	Change in patient-rated quality of life	Change in patient-rated quality of life	At 6,12,18,24,36,48,60 months after completion of treatment
Secondary	Overall survival	Overall survival	At 1,2,3,4 and 5 years after completion of treatment
Secondary	Change in locoregional tumour control	Change in locoregional tumour control	At 1,2,3,4 and 5 years after completion of treatment
Secondary	Laryngo-oesophageal dysfunction-free survival	Laryngo-oesophageal dysfunction-free survival	At 1,2,3,4 and 5 years after completion of treatment
Secondary	Change in patient-rated symptoms	Change in patient-rated symptoms	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
Secondary	Late toxicity	Late toxicity	At 12 months after last day of completion of treatment
Secondary	Late toxicity	Late toxicity	At 18 months after last day of completion of treatment
Secondary	Late toxicity	Late toxicity	At 24 months after last day of completion of treatment
Secondary	Late toxicity	Late toxicity	At 36 months after last day of completion of treatment
Secondary	Late toxicity	Late toxicity	At 48 months after last day of completion of treatment
Secondary	Late toxicity	Late toxicity	At 60 months after last day of completion of treatment
Secondary	Thyroid Stimulating Hormone (TSH)	TSH levels (mU/L) measured in blood	At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy.
Secondary	Free Thyroxine-4 (FT4)	FT4 levels (pmol/L) measured in blood	At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy.