ART-02: Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06116019
• Collaborator: (none)
• Enrollment: 649
• Location: 1
• Anticipated Duration (Months): 47.9
• Patients Per Site Per Month: 13.5

Study Details

Study Description

Brief Summary

The study focuses on the scientific and clinical evaluation of online adaptive radiotherapy (ART) using the Varian/SHS ETHOS treatment system. In this study, radiation treatment plans are dynamically adjusted on a daily basis over several weeks of therapy to account for anatomical shifts in either the tumour or adjacent normal tissue - a capability that has been difficult to achieve due to technical limitations. With the ETHOS accelerator, such real-time adjustments can be made based on cone beam computed tomography (CBCT). This is a prospective observational study with the primary objective of investigating the feasibility and acceptability of performing ART with ETHOS for different tumour entities. The study will also evaluate the feasibility of integrating multi-parametric data sets into the ART workflow, such as standardised electronic feedback on treatment toxicity from both patients (ePROMS) and physicians (ePRT).

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Head and Neck Cancer; NSCLC; SCLC; Esophageal Cancer; Bladder Cancer; Rectum Cancer; Cervix Cancer; Other Carcinoma	Radiation: Online adaptive radiation therapy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 649 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Study on Online Adaptive Radiotherapy (ART) Using the ETHOS Linear Accelerator for Various Tumor Entities and the Feasibility of Integrating Multi-Parametric Patient Data Into the Adaptive Workflow
• Actual Study Start Date: Oct 11, 2023
• Anticipated Primary Completion Date: Oct 9, 2026
• Anticipated Study Completion Date: Oct 9, 2027

Outcome Measures

Primary Outcome Measures

1. Number of Successfully Completed Adaptive Radiotherapy Sessions in Patients with Various Tumor Entities [Throughout the treatment period, up to 6 weeks.]

   This measure evaluates the success rate of adaptive radiotherapy sessions with ETHOS across different tumor types. It measures the total count of adaptive treatment sessions that were completed without interruption or complication for each patient.

Secondary Outcome Measures

1. Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Target Coverage in Patients with Various Tumor Entities [Throughout the treatment period, up to 6 weeks.]

   This measure quantifies the adaptive treatment sessions for which a dosimetric advantage for target coverage is detected in patients undergoing adaptive radiotherapy across different tumor types.

2. Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Organs at Risk in Patients with Various Tumor Entities [Throughout the treatment period, up to 6 weeks.]

   This measure quantifies the adaptive treatment sessions for which a dosimetric advantage for organs at risk is detected in patients undergoing adaptive radiotherapy across different tumor types.

3. Number of Adaptive Radiotherapy Sessions with Dosimetric Benefit to Organs at Risk Following ePROMs and ePRT-based Plan Adjustments in Patients with Various Tumor Entities [Throughout the treatment period, up to 6 weeks.]

   This measure quantifies the adaptive treatment sessions for which in silico analysis identifies a potential dosimetric advantage to organs at risk following ePROMs and ePRT-based plan adjustments.

4. Patient Reported Toxicity [2 years]

   Frequency and severity of treatment-related toxicities in patients as scored using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE)

5. Physician Reproted Toxicity [2 years]

   Frequency and severity of treatment-related toxicities in patients as scored using the the Common Terminology Criteria for Adverse Events (CTCAE)

6. Impact of Adaptive Radiotherapy on Patient Quality of Life Assessed by EORTC QLQ-C30 [2 years]

   This measure evaluates the quality of life of patients undergoing adaptive radiotherapy using the EORTC QLQ-C30 scale.

7. Fatigue Levels in Patients Undergoing Adaptive Radiotherapy Assessed by FACIT-F [2 years]

   This measure quantifies the fatigue experienced by patients undergoing adaptive radiotherapy as determined by the FACIT-F scale.

8. Local Control [2 years]

   Freedom from local progression after adaptive radiotherapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Adult patients (>18 years)

• All tumor entities with an indication for radiotherapy and/or chemoradiotherapy

• Signed informed consent

Exclusion Criteria:

• Pregnancy

• Patients who are not capable of giving consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité - Universitätsmedizin	Berlin		Germany

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Goda Kalinauskaite, Principal Investigator, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT06116019
• Other Study ID Numbers: 3000902
• First Posted: Nov 3, 2023
• Last Update Posted: Nov 3, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Goda Kalinauskaite, Principal Investigator, Charite University, Berlin, Germany: online adaptive radiation therapy; ART; cone beam CT; ePROMS
• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Rectal Neoplasms

Study Results

No Results Posted as of Nov 3, 2023