Clinical trial · Observational
ROCOCO - Low Grade Glioma - Planning Study
In Silico Clinical Trial on Irradiation Low Grade Glioma, Comparing Photon and Proton Therapy: A Multicentric Planning Study Based on a Reference Dataset of Patients
- 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)
The cost of particle therapy (PT) are considerably higher than conventional radiotherapy (RT) with photons. Considering potential dosimetric advantages of PT, it is necessary to determine if PT are more cost-effective than photons per indication regarding quality of life, survival, and progression free survival. Given the lack of evidence for the benefit of particle therapy in relevant cases, investigators proposed an in silico trial to investigate to what extend proton therapy decrease the amount of irradiated normal tissue and, consequently, the risk of side effects in the surrounding normal tissue as well as the risk of secondary tumors. Given validated dose-response curves and/or NTCP models, a 10% lower mean dose of proton therapy on normal tissue compared to photon therapy should result in at least a 20% lower risk of side effects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Grade Glioma | Low Grade Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Dmean
- timeFrame
- 1 month
- description
- The normal tissue dose volume parameters per tumor type are defined as Hippocampus: Dmean
- measure
- Dmax
- timeFrame
- 1 month
- description
- The normal tissue dose volume parameters per tumor type are defined as Hippocampus: Dmax
Secondary outcomes (1)
- measure
- Normal Tissue Complication Probability
- timeFrame
- 1 month
- description
- Based on the OAR's radiation exposure, normal tissue complication probability (NTCP) will be calculated using existing models or existing dose response curves.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Low Grade Glioma patients * Treated with radical intent Exclusion Criteria: * No Low Grade Glioma
References
Publications (0)
Data not yet available