Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online adaptive radiation therapy | Radiation | Daily cone-beam CT based online adaptive radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Target Coverage in Patients with Various Tumor Entities | 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. | Throughout the treatment period, up to 6 weeks. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Goda Kalinauskaite, MD | Contact | +49 30 450 527318 | goda.kalinauskaite@charite.de | |
| Carolin Senger, MD | Contact | +49 30 450 527318 | carolin.senger@charite.de |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin | Recruiting | Berlin | Germany |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004938 | Esophageal Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D012004 | Rectal Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Organs at Risk in Patients with Various Tumor Entities | 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. | 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 | 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. | Throughout the treatment period, up to 6 weeks. |
| Patient Reported Toxicity | 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) | 2 years |
| Physician Reproted Toxicity | Frequency and severity of treatment-related toxicities in patients as scored using the the Common Terminology Criteria for Adverse Events (CTCAE) | 2 years |
| Impact of Adaptive Radiotherapy on Patient Quality of Life Assessed by EORTC QLQ-C30 | This measure evaluates the quality of life of patients undergoing adaptive radiotherapy using the EORTC QLQ-C30 scale. | 2 years |
| Fatigue Levels in Patients Undergoing Adaptive Radiotherapy Assessed by FACIT-F | This measure quantifies the fatigue experienced by patients undergoing adaptive radiotherapy as determined by the FACIT-F scale. | 2 years |
| Local Control | Freedom from local progression after adaptive radiotherapy | 2 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |