Pelvic Cancer Registry for Online Adapted Radiotherapy (PRoART)

Pelvic and Thoracic Cancer Treated With Online Adapted Radiotherapy: A Prospective Registry-based Phase-II Trial

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

Study Overview

• Status: Recruiting
• Conditions: Pelvic Tumor; Thoracic Tumor

Detailed 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

• Study Type: Observational
• Enrollment (Estimated): 846

Contacts and Locations

• Study Contact: Name: Rami El Shafie; Email: rami.elshafie@med.uni-goettingen.de
• Study Contact Backup: Name: Laura Anna Fischer; Phone Number: +49 551 3964501; Email: laura-anna.fischer@med.uni-goettingen.de

Study Locations

• Germany
  • Göttingen, Germany
    • Recruiting
    • University Medical Center, Departement of Radiation Oncology
    • Contact: Laura Anna Fischer; Email: laura-anna.fischer@med.uni-goettingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
IGRT; Patients with pelvic or thoracic tumors with an indication for radiotherapy treated with conventional IGRT (Image Guided Radiotherapy).
oART; Patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART (online Adaptied Radiotherapy).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Medical Center Goettingen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: online Adaptive Radiotherapy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pelvic Neoplasms; Thoracic Neoplasms
• Other Study ID Numbers: 2023-02727

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No