Bladder Cancer, Cervix Cancer, Esophageal Cancer, Head and Neck Cancer, NSCLC, Other Carcinoma, Prostate Cancer, Rectum Cancer, SCLC
Conditions
Keywords
online adaptive radiation therapy, ART, cone beam CT, ePROMS
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).
Interventions
RADIATIONOnline adaptive radiation therapy
Daily cone-beam CT based online adaptive radiation therapy
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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) |
| 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. |
| 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. |
| 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. |
| Local Control | 2 years | Freedom from local progression after adaptive radiotherapy |
| 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) |
Countries
Germany
Contacts
Primary ContactGoda Kalinauskaite, MD
Backup ContactCarolin Senger, MD
Outcome results
None listed