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

Standard Follow-up Program (SFP) for Head and Neck Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation (SFP Head & Neck)

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Radiation: Radiotherapy (primary or postoperative)

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

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: J.A. Langendijk, Prof. Dr.; Phone Number: +31503615532; Email: j.a.langendijk@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700RB
    • Recruiting
    • University Medical Center Groningen
    • Contact: J.A. Langendijk, Prof. Dr.; Phone Number: +31503615532; Email: j.a.langendijk@umcg.nl
    • Principal Investigator: J.A. Langendijk, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late toxicity	Late toxicity	At 6 months after last day of completion of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Overall survival	Overall survival	At 1,2,3,4 and 5 years after completion of treatment
Change in locoregional tumour control	Change in locoregional tumour control	At 1,2,3,4 and 5 years after completion of treatment
Laryngo-oesophageal dysfunction-free survival	Laryngo-oesophageal dysfunction-free survival	At 1,2,3,4 and 5 years after completion of treatment
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
Late toxicity	Late toxicity	At 12 months after last day of completion of treatment
Late toxicity	Late toxicity	At 18 months after last day of completion of treatment
Late toxicity	Late toxicity	At 24 months after last day of completion of treatment
Late toxicity	Late toxicity	At 36 months after last day of completion of treatment
Late toxicity	Late toxicity	At 48 months after last day of completion of treatment
Late toxicity	Late toxicity	At 60 months after last day of completion of treatment
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.
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.

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: J.A. Langendijk, Prof. Dr., University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: March 27, 2015
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (Estimated): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Acute toxicity; Late toxicity; Proton therapy; NTCP models; Patient-rated outcomes
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: SFP2007-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO