Clinical trial · Observational
Radiotherapy Treatment Planning Comparison Using SBRT-PATHY (Photons) Versus CARBON-PATHY for Unresectable Bulky Tumors
NCT06390657CI-TRIAL-00089510S-C-PATHYwithdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): the project was not started.
Summary
Brief summary (as posted)
This study uses a novel unconventional radiotherapy technique, consisting of high dose PArtial Tumor irradiation targeting exclusively the HYpoxic segment of unresectable bulky tumors delivered either with photons (SBRT-PATHY) or with carbon-ions (CARBON-PATHY) while sparing the peritumoral immune microenvironment (PIM).
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Planning CT, MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Phase A: retrospective planning study
- description
- Simulation CTs of up to ten patients with bulky (\>6cm) tumors will be selected. This will be used for optimization of contouring and planning strategy.
- interventionNames
- Other: Planning CT, MRI
- label
- Phase B: prospective planning study
- description
- Ten patients with bulky tumors (\>6cm) recommended to receive RT with CT and MRI planning will be accrued. MRI DCE sequence (20-30mins) will be added if not requested for clinical use. They will be treated with standard clinical plans. Every effort will be made to include equal numbers of patients (2-3) from head and neck, thorax, abdomen and pelvis. Planning images will be used for the purpose of dosimetric comparison between SBRT-PATHY and CARBON-PATHY radiation plans.
- interventionNames
- Other: Planning CT, MRI
Primary outcomes (2)
- measure
- Phase A: optimization of contouring and planning using PATHY strategy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent (for use their planning CT and MR data for study specific planning) 2. Malignant solid bulky primary or recurrent tumor with diameter of ≥6 cm 3. Age \> 18 years 4. Radiation planning CT (with IV contrast) and MRI (with or without IV contrast) is planned Exclusion Criteria: 1. Patients without bulky lesions, 2. Contraindication to i.v. CT and MRT contrast medium administration, particularly estimated glomerular filtration rate (GFR) less than 45 mL/min/1.73 m². 3. Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control, 4. Any condition that, in the opinion of the investigators, would interfere with treatment planning or interpretation of study results Note (1): criterion n°4 will be evaluated on the four eyes principle, evaluated by both Principle Investigator and Sub-Investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.