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

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02435576
Study type	Observational [Patient Registry]
Source	University Medical Center Groningen
Contact	J.A. Langendijk, Prof. Dr.
Phone	+31503615532
Email	j.a.langendijk@umcg.nl
Status	Recruiting
Phase
Start date	March 2007
Completion date	January 2028

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms