CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 846 target
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 3
  • Pelvic or thoracic tumors with indication for radiotherapy
  • Age ≥18 years
  • Informed consent provided
Key exclusion· 1
  • Prior radiotherapy at affected site

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06185062
NCT06185062N/ARecruitingOn TrackUpdated 28mo ago

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

University Medical Center Goettingen·observational·Posted Dec 29, 2023·Updated Feb 8, 2024

In Brief

An observational study for Pelvic Tumor and Thoracic Tumor. Currently recruiting, targeting 846 participants across 1 site.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ARecruiting
2024202520262027202820292030
First PostedDec 29, 2023
Enrollment StartJan 1, 2024
Primary CompletionSep 1, 2029
Study CompletionApr 1, 2030
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 2.5 years agoPrimary completion in 3.2 years