Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06185062
Other study ID # 2023-02727
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date April 2030

Study information

Verified date February 2024
Source University Medical Center Goettingen
Contact Laura Anna Fischer
Phone +49 551 3964501
Email laura-anna.fischer@med.uni-goettingen.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This prospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios. Primary endpoint: - 10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART Secondary endpoints: - Clinical endpoints: Tumor control, late toxicities compared to conventional irradiated patients, quality of life and patient-reported outcomes - Technical endpoints: Target volume, target coverage, dose to organs at risk, anatomical variability score


Description:

Background: Conventional Radiotherapy (Image Guided Radiotherapy, IGRT) requires a CT-based treatment planning process a priori. During this process, a treatment plan is calculated, which then is applied to the patient with a linear accelerator on a daily basis, possibly using image guidance to account for variability in patient position. However, daily changes of the anatomy of targets and organs at risk (OARs) can only be addressed by applying additional safety margins, resulting in larger irradiated volumes and possibly higher toxicity. A promising and innovative technique for margin and in consequence toxicity reduction is online Adaptive Radiotherapy (oART) using daily imaging to create a "plan of the day" aligned to the actual anatomy by means of artificial intelligence (AI) and with the patient on the treatment couch. This approach is especially promising in the pelvic region due to the high anatomic variability, e.g. caused by peristalsis or volume changes of bladder and rectum. Furthermore, the application of oART in the field of thoracic tumors is being evaluated. oART is an already established form of treatment which is used regulary everyday in clinical practice and is not a study-related intervention. A direct comparison of both techniques IGRT vs. oART is missing. Methods: This prospective and retrospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios as follows: - oART - Applied treatment: AI-based daily treatment plan creation, adapted to daily anatomy - Virt 1 - Hypothetical dose distribution of initial treatment plan, based on the initial planning CT - Virt 2 - Hypothetical dose distribution of initial treatment plan, applied to the anatomy of the day as depicted by cone-beam CT at the treatment machine


Recruitment information / eligibility

Status Recruiting
Enrollment 846
Est. completion date April 2030
Est. primary completion date September 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility INCLUSION CRITERIA - Patients with pelvic or thoracic tumors with an indication for radiotherapy - Patient information and declaration of consent - Patients age = 18 years EXCLUSION CRITERIA - Prior radiotherapy in affected site

Study Design


Locations

Country Name City State
Germany University Medical Center, Departement of Radiation Oncology Göttingen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of acute radiotherapy related toxicity 10% reduction in the rate of acute radiotherapy related toxicity (= CTCAE II°, v5.0) using oART until 12 weeks post RT
See also
  Status Clinical Trial Phase
Terminated NCT00320996 - SGO Society of Gynecologic Oncologists Data Outcomes Project
Not yet recruiting NCT06418243 - Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors
Completed NCT04980729 - A Positioning Navigation Template for Assisting the Placement of Modular Hemipelvic Endoprostheses for Patients Undergoing Pelvic Bone Tumor Resection. N/A
Recruiting NCT05739812 - The Efficacy and Safety of Chinese Domestic Surgical Robot System in Urological Telesurgery N/A
Not yet recruiting NCT05633134 - Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes N/A
Completed NCT03022539 - Repeat CT Scans for Evaluation of Inter- and Intrafraction Motion and it's Effect on Radiotherapy Dose Distribution During Curative Radiotherapy for Pelvic Tumours