Radiotherapy Treatment Planning Comparison Using SBRT-PATHY (Photons) Versus CARBON-PATHY for Unresectable Bulky Tumors

Cancer Clinical Trial

— S-C-PATHY  

Official title:

Radiotherapy Treatment Planning Comparison Using SBRT-PATHY (Photons) Versus CARBON-PATHY for Unresectable Bulky Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06390657
• Other study ID #: S-C-PATHY-MA-122022
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: EBG MedAustron GmbH
• Contact: Slavisa Tubin, M.D.
• Phone: +43 2622 26 100
• Email: slavisa.tubin[@]medaustron.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

This study will be conducted as a two phase study. Phase A is a retrospective study. Up to 10 patients with bulky (>6cm tumors) previous planned with planning CT with IV contrast will be selected for planning and dosimetry comparison. This is performed to optimize the contouring and planning procedures. Phase B is a prospective study. Ten patients with bulky (>6cm tumor) requiring radiotherapy, with planning CT and MR with IV contrast will be accrued. Every effort will be made to include equal numbers of patients (2-3) from head and neck, thorax, abdomen and pelvis. Their images will be used for planning and dosimetry comparison. Patients will be treated according to clinical plans. The study plans will not be used for treatment. Treatment plans for Photon delivery (SBRT-PATHY) and Carbon delivery (CARBON-PATHY) to deliver 30 Gy in three fractions will be planned to be delivered to the BTV will be performed. SBRT-PATHY plans will be generated at the Princess Margaret Cancer Center (PMCC, Toronto, Canada) while CARBON-PATHY plans will be generated at the MedAustron Center for Particle Therapy and Research (W. Neustadt, Austria). The objective is to compare the dosimetric profile achievable using SBRT-PATHY (using photons) and CARBON-PATHY (using carbon-ions) for unresectable bulky tumors and surrounding tissues.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Planning CT, MRI
SBRT-PATHY and CARBON-PATHY planning is performed for study purposes only. Patients will be treated according to standard radiotherapy as per institutional policies. The planning images (CT, MRI) will be anonymized and used for planning purposes only.

Locations

Country	Name	City	State
Austria	EBG MedAustron GmbH	Wiener Neustadt	Niederösterreich

Sponsors (2)

Lead Sponsor	Collaborator
EBG MedAustron GmbH	The Princess Margaret Cancer Foundation

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase A: optimization of contouring and planning using PATHY strategy	The objective of phase A is to optimize the target delineation, planning strategy and techniques for SBRT-PATHY at Princess Margaret and CARBON-PATHY at MedAustron.	18 months (phase A and B combined)
Primary	Phase B: optimal coverage of Bystander tumor volume (BTV) while allowing the maximal radiation-sparing of PIM and regional lymph nodes	a prospective identification of 10 patients who are recommended to receive radiotherapy fulfilling the inclusion criteria. SBRT-PATHY and CARBON-PATHY planning is perfomed for study purposes only. A planning comparison between SBRT-PATHY (using photons) and CARBON-PATHY (using carbon-ions) based on dosimetric consideration achieved for the targeted BTV, non-targeted surrounding NTV (normoxic tumor segment), PIM, regional metastases (i.e. local regional involved nodes and distant metastases located within 15 cm cranial caudal to GTV), regional uninvolved lymph nodes and surrounding organs at risk (OAR) will be performed.	18 months (phase A and B combined)
Secondary	Phase B: Dosimetric-sparing of normoxic tumor volume (NTV)	The normoxic tumor segment (NTV) will be created by subtracting the BTV from the GTV, representing the remaining peripheral tumor segment outside the BTV.	18 months (phase A and B combined)
Secondary	Phase B: Dosimetric-sparing of Organs at risk (OAR) and regional nodes	The OAR will be delineated on MRT images at the level of the treated area. Particularly normal structures involved by or in the close proximity to the tumor such as vessels, nerves, or hollow organs will be contoured. Contours will be checked and refined on the co-registered simulation CT images.	18 months (phase A and B combined)
Secondary	Phase B: Feasibility for dosimetric-sparing of regional/distant metastases as abscopal tumor sites (if present)	Abscopal tumor site(s), corresponding to radiographic evidence of the regional (for ex. lymph nodes) metastases, will be delineated on whichever images that clearly demonstrate their presence, including simulation CT or MRT.	18 months (phase A and B combined)