NCT04242342

Adaptative MR-Guided Stereotactic Body Radiotherapy of Liver Tumors

Phase II of Adaptative Magnetic Resonance-Guided Stereotactic Body Radiotherapy (SBRT) for Treatment of Primary or Secondary Progressive Liver Tumors

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Centre Georges Francois Leclerc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hepatic metastases are common in solid cancers (up to 30% of patients with colorectal cancer and up to 50% of patients during their follow-up). The incidence of primary liver cancer increases due to the increase in chronic liver diseases induced by excessive alcohol consumption, hepatitis B and C viruses, and excess fat in the liver. Surgical excision of these liver lesions is the reference treatment but it cannot always be realised. Stereotactic radiotherapy is a recent technique proposed to hepatic metastases treatment from solid cancers and primary hepatic lesions (HCC or cholangiocarcinomas); it is possible to deliver high doses of radiation in the most conformational way possible in order to limit the irradiation of the non-tumor liver. The results of this stereotactic radiotherapy are currently very good with control rates of 75 to 80% at 1 and 2 years with acceptable rates of severe toxicities of 10%. However, the fear of hepatic, digestive (colon, esophagus, stomach) or even cardiac toxicities limits its using to the majority of patients because coupled with a conventional scanner it do not allow direct visualization of the lesion. Due to its non-irradiating nature, MRI guided stereotactic radiotherapy can generate continuous imaging, during the irradiation session, offering " in live " a visualization of the tumor target and organs at risk of proximity. In increasing the precision and safety in the delivery of irradiation, it allows to hope for several areas for improvement of treatment: * reduced uncertainty margins * an increase in the dose delivered * the accessibility of tumor lesions near sensitive organs (esophagus, stomach, heart chambers, intestines, duodenum, right kidney). More, this accelerator allows a re-optimization of the initial dosimetric plan to the anatomical changes of the day to allow an MRI guided adaptive radiotherapy.

Detailed description

The MRI guided stereotactic radiotherapy of hepatic lesions with an MRIdian® Linac tested in this study will allow: * to see the tumor target in live with a non-irradiating imaging * a reduction of the volume of non-tumor liver irradiated at high doses * An progession of the dose delivered to the tumor lesion to allow tumor control to be increased. * a new dosimetric plan adapted each day to the new contours to avoid a risk of severe digestive toxicity while ensuring optimal treatment, at an appropriate dose, of the tumor volume.

Conditions

• Radiotherapy

Interventions

Type	Name	Description
RADIATION	Adaptative MR-Guided Stereotactic Body Radiotherapy	If lesion near organs at risk: * Prescription of 50 Gy in 5 fractions of 10 Gy * 3 sessions per week, with MRI guided stereotactic radiotherapy and daily adaptive treatment If lesion far of organs at risk: * Prescription of 60 Gy in 6 fractions of 10 Gy * 3 sessions per week, with MRI guided stereotactic radiotherapy without daily adaptive treatment

Timeline

• Start date: 2020-01-20
• Primary completion: 2029-01-20
• Completion: 2029-01-20
• First posted: 2020-01-27
• Last updated: 2024-02-12

Locations

1 site across 1 country: France