Prospective Validation of Adaptive Radiotherapy (ART) in Patients With Head and Neck Tumors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Essen

About this trial

Adaptive radiotherapy (ART) includes image-guided radiotherapy (IGRT) and also offers further possibilities for plan adaptation. A particularly high benefit can be expected for patients in whom the clinical target volume (CTV) can show a significant change in shape from fraction to fraction due to anatomical deviations. The shape and position constancy of the CTV during the course of the series is examined in this trial. Dosimetric disadvantages of this type have not been reported so far. The aim of this study is to identify patients who benefit from ART at an early stage and to select them for this method, and then to continue to offer ART to this patient group. If a relevant reduction in the minimum planning target volume (PTV) margins with ART compared to IGRT is demonstrated in this study, patients could be treated with ART.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ECOG 0-1

Histopathology confirmation

Compliance

Tumor in the head and neck region

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Adaptive Radiotherapy

    Radiation

    Adaptive Radiotherapy in the head and neck region

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Adaptive RadiotherapyOther 1 intervention
Group B: Standard Treatment Arm, IGRTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Accumulated dose distribution in CTV

accumulated dose distribution in the clinical target volume, EUD \[Gy\]

Time frame
2 weeks

Secondary outcomes

1

dysphagia assessment scores

dysphagia assessment scores

Time frame
2 weeks to 5 years
2

Minimally isotropic PTV margin

Minimally isotropic PTV margin \[mm\]

Time frame
2 months
3

Progression free survival (PFS)

Progression free survival (PFS)

Time frame
2 months to 5 years
4

overall survival (OS)

overall survival (OS)

Time frame
2 months to 5 years

Other outcomes

Sponsors and contacts

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