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NCT Number: NCT02435576

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location status: Recruiting

Location contact

J.A. Langendijk, Prof. Dr.

CONTACT

[email protected]

+31503615532

J.A. Langendijk, Prof. Dr.

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiotherapy (primary or postoperative)

Radiation

Primary outcomes

  1. Late toxicity

    Time frame: At 6 months after last day of completion of treatment

    Late toxicity

Secondary outcomes

  1. Change in acute toxicity

    Time frame: 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 acute toxicity

  2. Change in patient-rated quality of life

    Time frame: At 6,12,18,24,36,48,60 months after completion of treatment

    Change in patient-rated quality of life

  3. Overall survival

    Time frame: At 1,2,3,4 and 5 years after completion of treatment

    Overall survival

  4. Change in locoregional tumour control

    Time frame: At 1,2,3,4 and 5 years after completion of treatment

    Change in locoregional tumour control

  5. Laryngo-oesophageal dysfunction-free survival

    Time frame: At 1,2,3,4 and 5 years after completion of treatment

    Laryngo-oesophageal dysfunction-free survival

  6. Change in patient-rated symptoms

    Time frame: 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 symptoms

  7. Late toxicity

    Time frame: At 12 months after last day of completion of treatment

    Late toxicity

  8. Late toxicity

    Time frame: At 18 months after last day of completion of treatment

    Late toxicity

  9. Late toxicity

    Time frame: At 24 months after last day of completion of treatment

    Late toxicity

  10. Late toxicity

    Time frame: At 36 months after last day of completion of treatment

    Late toxicity

  11. Late toxicity

    Time frame: At 48 months after last day of completion of treatment

    Late toxicity

  12. Late toxicity

    Time frame: At 60 months after last day of completion of treatment

    Late toxicity

  13. Thyroid Stimulating Hormone (TSH)

    Time frame: At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy.

    TSH levels (mU/L) measured in blood

  14. Free Thyroxine-4 (FT4)

    Time frame: At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy.

    FT4 levels (pmol/L) measured in blood

Study contacts

Contact information is provided by the study sponsor or research team.

J.A. Langendijk, Prof. Dr.

CONTACT

[email protected]

+31503615532

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: H&NTOX

Important dates

Study start
2007
Primary completion
2025
Study completion
2028
First posted
May 6, 2015
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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