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Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)

NCT ID: NCT06116019

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

649 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-11

Study Completion Date

2027-10-09

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Online adaptive radiation therapy

Daily cone-beam CT based online adaptive radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Goda Kalinauskaite

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Charité - Universitätsmedizin

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Goda Kalinauskaite, MD

Role: CONTACT

[email protected]
+49 30 450 527318

Carolin Senger, MD

Role: CONTACT

[email protected]
+49 30 450 527318

Facility Contacts

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Goda Kalinauskaite

Role: primary

[email protected]

Other Identifiers

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3000902

Identifier Type: -

Identifier Source: org_study_id

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