Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
The MRI guided stereotactic radiotherapy of hepatic lesions with an MRIdian® Linac tested in this study will allow:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Patient with a localized primary tumor (hepatocellular carcinoma or cholangiocarcinoma) or a secondary hepatic localization of a solid carcinoma, with one to three hepatic lesions accessible to a treatment by stereotactic radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptative MR-Guided Stereotactic Body Radiotherapy | Radiation | If lesion near organs at risk:
If lesion far of organs at risk:
|
| Measure | Description | Time Frame |
|---|---|---|
| local control at 2 years | lack of progression according to RECIST criteria | 2 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
MRI contraindication
Pregnant or breastfeeding woman.
Patient with decompensated liver cirrhosis or cirrhosis> Child B7
Patient previously irradiated in the planned treatment area.
Refusal of patient's consent.
Patient unable to give his consent, under guardianship or unable to submit to the treatment protocol or protocol follow-up.
History of another malignant tumor except:
Known hypersensitivity to gadolinium or other gadolinium chelates.
Patient participating in another therapeutic trial which would require the administration of experimental treatment during the period between inclusion and the end of radiotherapy treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges François Leclerc | Dijon | 21000 | France |
Not provided
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D008107 |
| Liver Diseases |