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

EBG MedAustron

Status: Withdrawn

Conditions: Cancer

Treatments: Other: Planning CT, MRI

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06390657

S-C-PATHY-MA-122022

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups

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.

Treatment:

Other: Planning CT, MRI

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.

Treatment:

Other: Planning CT, MRI