Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)

NCT06116019 | Recruiting FDA Device

• 1 other identifier: 3000902
• Study Type: observational
• Target: 649
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer; Head and Neck Cancer; NSCLC; SCLC; Esophageal Cancer; Bladder Cancer; Rectum Cancer; Cervix Cancer; Other Carcinoma

Keywords

online adaptive radiation therapy; ART; cone beam CT; ePROMS

Outcome Measures

Primary Outcomes (1)

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

  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.

  Throughout the treatment period, up to 6 weeks.

Secondary Outcomes (8)

• 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.

• 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.

• 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.

• Patient Reported Toxicity

  2 years

• Physician Reproted Toxicity

  2 years

Interventions

Online adaptive radiation therapy RADIATION

Daily cone-beam CT based online adaptive radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients older than 18 years, diagnosed with malignancies that have an indication for radiation therapy, with or without concurrent chemotherapy, and who are receiving online adaptive radiation therapy at the Department of Radiation Oncology at Charité.

You may qualify if:

• Adult patients (\>18 years)
• All tumor entities with an indication for radiotherapy and/or chemoradiotherapy
• Signed informed consent

You may not qualify if:

• Pregnancy
• Patients who are not capable of giving consent

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin

Berlin, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Head and Neck Neoplasms; Esophageal Neoplasms; Urinary Bladder Neoplasms; Rectal Neoplasms; Uterine Cervical Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Goda Kalinauskaite, MD

CONTACT

+49 30 450 527318; goda.kalinauskaite@charite.de

Carolin Senger, MD

CONTACT

+49 30 450 527318; carolin.senger@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: November 3, 2023
• Study Start: October 11, 2023
• Primary Completion (Estimated): October 9, 2026
• Study Completion (Estimated): October 9, 2027
• Last Updated: November 3, 2023

Record last verified: 2023-10

Locations

DE (1)