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

Head and Neck Cancer Clinical Trial

— ART in HNT  

Official title:

Adaptive Radiotherapy in the Treatment of Patients With a Histologically Confirmed Malignant Tumor in the Head and Neck Region: Prospective Validation of ART in Patients With HNT (Prospektive Validierung Der ART Bei Patientinnen Und Patienen Mit Kopf-Hals Tumoren,)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214611
• Other study ID #: 23-11129-BO
• Secondary ID: DRKS00033144
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Essen
• Contact: Maja PD Dr. med. Guberina, PD Dr. med. (MD), specialist
• Phone: +492017232321
• Email: maja.guberina[@]uk-essen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The aim here is to prospectively evaluate modern technical standards. In the last 25 years, radiotherapy has developed rapidly away from two-dimensional procedures towards volume-modulated, three-dimensional techniques. But here, too, there is a broad radiotherapeutic spectrum due to the high technical diversity in radiotherapy and ever newer technical innovations. (1) Definitive radiochemotherapy is standard of care for locally advanced head and neck tumors. The aim of this study is to monitor the influence of the new technical therapy standards (therapy options in application: volume-modulated rapid-arc technique (VMAT) / online onboard image-guidance (IGRT) and adaptive re-planning, using the linear accelerator ETHOS currently established and installed at the Department of Radiotherapy in December 2021) as a function of dose parameters for quality assurance of feasibility.

Therapy with ETHOS represents a comprehensive new treatment option that is tailored and individualized from the initial planning and adjustment on the treatment table to radiation monitoring of the whole therapy.

Online-adaptive radiotherapy (ART) allows the dose distribution to be adapted to the anatomical changes online and immediately before each radiation fraction. Adaptive radiotherapy is a further development of image-guided radiotherapy (IGRT), which is now standard of care in radiotherapy. In contrast to ART, with IGRT the radiation plan cannot be adapted to deformations of the body from radiation fraction to radiation fraction, e.g. through different positioning of the tongue or jaw.

This trial creates the basis for standardizing treatment parameters as far as possible, but also for introducing improvements in the treatment of future patients in a personalized and individualized form.

Standard therapy can be further optimized using modern equipment and high-precision linear accelerators.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. ECOG 0-1

2. Histopathology confirmation

3. Compliance

4. Tumor in the head and neck region

5. Indication for radiotherapy

Exclusion Criteria:

1. Pregnancy

Related Conditions & MeSH terms

• Deglutition Disorders
• Head and Neck Cancer
• Head and Neck Neoplasms
• Optimized Treatment
• Radiation

Intervention

Radiation:
• Adaptive Radiotherapy
Adaptive Radiotherapy in the head and neck region

Locations

Country	Name	City	State
Germany	Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West	Essen	Germany / NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Chetty IJ, Martel MK, Jaffray DA, Benedict SH, Hahn SM, Berbeco R, Deye J, Jeraj R, Kavanagh B, Krishnan S, Lee N, Low DA, Mankoff D, Marks LB, Ollendorf D, Paganetti H, Ross B, Siochi RA, Timmerman RD, Wong JW. Technology for Innovation in Radiation Oncology. Int J Radiat Oncol Biol Phys. 2015 Nov 1;93(3):485-92. doi: 10.1016/j.ijrobp.2015.07.007. Epub 2015 Jul 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accumulated dose distribution in CTV	accumulated dose distribution in the clinical target volume, EUD [Gy]	2 weeks
Secondary	dysphagia assessment scores	dysphagia assessment scores	2 weeks to 5 years
Secondary	Minimally isotropic PTV margin	Minimally isotropic PTV margin [mm]	2 months
Secondary	Progression free survival (PFS)	Progression free survival (PFS)	2 months to 5 years
Secondary	overall survival (OS)	overall survival (OS)	2 months to 5 years
Secondary	dose organs at risk (OAR)	dose organs at risk (OAR)	2 weeks
Secondary	Side effects, LENT-SOMA	LENT-SOMA criteria and score for Adverse Events (CTCAE)	2 months to 5 years
Secondary	quality of life (EORTC)	quality of life (EORTC)	2 months to 5 years
Secondary	Side effects (CTC AE)	Common Terminology Criteria for Adverse Events (CTCAE)	2 months to 5 years