Adaptative MR-Guided Stereotactic Body Radiotherapy of Liver Tumors (RASTAF)
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|ClinicalTrials.gov Identifier: NCT04242342|
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : May 25, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Radiotherapy||Radiation: Adaptative MR-Guided Stereotactic Body Radiotherapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II of Adaptative Magnetic Resonance-Guided Stereotactic Body Radiotherapy (SBRT) for Treatment of Primary or Secondary Progressive Liver Tumors|
|Actual Study Start Date :||November 26, 2019|
|Estimated Primary Completion Date :||November 26, 2023|
|Estimated Study Completion Date :||November 26, 2025|
Experimental: Experimental arm
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.
Radiation: Adaptative MR-Guided Stereotactic Body Radiotherapy
If lesion near organs at risk:
If lesion far of organs at risk:
- local control at 2 years [ Time Frame: 2 years ]lack of progression according to RECIST criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242342
|Contact: Magali Rouffiac Thouant||03 80 73 75 firstname.lastname@example.org|
|Contact: Emlie REDERSTORFF||03 45 34 81 email@example.com|