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

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,)

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Optimized Treatment; Radiation; Adaptive Radiotherapy; Protection of Organs at Risk; Dysphagia Reduction
• Intervention / Treatment: Radiation: Adaptive Radiotherapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maja PD Dr. med. Guberina, PD Dr. med. (MD), specialist; Phone Number: +492017232321; Email: maja.guberina@uk-essen.de

Study Locations

• Germany
  • Germany / NRW
    • Essen, Germany / NRW, Germany, 45147
      • Recruiting
      • Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West
      • Contact: Maja Guberina, PD Dr. med. (MD), specialist; Phone Number: +492017232321; Email: maja.guberina@uk-essen.de
      • Contact: Ina Grübel
      • Principal Investigator: Maja Guberina, PD Dr. med. (MD)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Adaptive Radiotherapy; Adaptive Radiation Therapy	Radiation: Adaptive Radiotherapy; Adaptive Radiotherapy in the head and neck region; Other Names: Dysphagia optimized Adaptive Radiotherapy (ART)
Active Comparator: Standard Treatment Arm, IGRT	Radiation: Adaptive Radiotherapy; Adaptive Radiotherapy in the head and neck region; Other Names: Dysphagia optimized Adaptive Radiotherapy (ART)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accumulated dose distribution in CTV	accumulated dose distribution in the clinical target volume, EUD [Gy]	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dysphagia assessment scores	dysphagia assessment scores	2 weeks to 5 years
Progression free survival (PFS)	Progression free survival (PFS)	2 months to 5 years
overall survival (OS)	overall survival (OS)	2 months to 5 years
dose organs at risk (OAR)	dose organs at risk (OAR)	2 weeks
Minimally isotropic PTV margin	Minimally isotropic PTV margin [mm]	2 months
Side effects, LENT-SOMA	LENT-SOMA criteria and score for Adverse Events (CTCAE)	2 months to 5 years
quality of life (EORTC)	quality of life (EORTC)	2 months to 5 years
Side effects (CTC AE)	Common Terminology Criteria for Adverse Events (CTCAE)	2 months to 5 years

Collaborators and Investigators

• Sponsor: University Hospital, Essen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Adaptive Radiotherapy; Optimized treatment; Protection of organs at risk; Dysphagia reduction
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Head and Neck Neoplasms; Deglutition Disorders
• Other Study ID Numbers: 23-11129-BO; DRKS00033144 (Other Identifier: DRKS, Deutsches Register Klinischer Studien)

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes