Clinical trial · Observational
Pelvic Cancer Registry for Online Adapted Radiotherapy
Pelvic and Thoracic Cancer Treated With Online Adapted Radiotherapy: A Prospective Registry-based Phase-II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pelvic Tumor | — | UNRESOLVED | — |
| Thoracic Tumor | Thoracic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- oART
- description
- Patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART (online Adaptied Radiotherapy).
- label
- IGRT
- description
- Patients with pelvic or thoracic tumors with an indication for radiotherapy treated with conventional IGRT (Image Guided Radiotherapy).
Primary outcomes (1)
- measure
- Rate of acute radiotherapy related toxicity
- timeFrame
- until 12 weeks post RT
- description
- 10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDFischer LA, Fischer J, Scheele NC, Droege LH, Leu M, Guhlich M, Oelmann-Avendano JT, Hille A, Bendrich S, Donath S, Knaus O, Ziegler DA, Zwerenz CM, Anczykowski MZ, Ammon HE, Luise Bergau PF, Pagel CF, Schirmer MA, Wenzel AR, Frohn J, Bensberg J, Strauss A, Asendorf T, Schmitt D, Rieken S, El Shafie RA. Online adaptive radiotherapy in pelvic and thoracic cancers - comparing toxicities, clinical outcomes and technical parameters between conventional image-guided radiotherapy and online adaptive radiotherapy - the study protocol for the prospective, registry-based cohort study (PRoART). BMC Med Imaging. 2026 Aug 5;26(1):378. doi: 10.1186/s12880-026-02622-7. PMID 42557552