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NCT Number: NCT06116019

Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)

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).

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Key information

Conditions

Prostate Cancer Bladder Cancer Carcinoma Cervix Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases NSCLC Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Other Carcinoma Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Rectum Cancer SCLC Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Universitätsmedizin

Berlin, Germany

Location status: Recruiting

Location contact

Goda Kalinauskaite

CONTACT

[email protected]

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online adaptive radiation therapy

Radiation

Daily cone-beam CT based online adaptive radiation therapy

Primary outcomes

  1. Number of Successfully Completed Adaptive Radiotherapy Sessions in Patients with Various Tumor Entities

    Time frame: 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 outcomes

  1. Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Target Coverage in Patients with Various Tumor Entities

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 2 years

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

  8. Local Control

    Time frame: 2 years

    Freedom from local progression after adaptive radiotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Carolin Senger, MD

CONTACT

[email protected]

+49 30 450 527318

Goda Kalinauskaite, MD

CONTACT

[email protected]

+49 30 450 527318

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study 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

Acronym: ART-02

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 3, 2023
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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