Adaptative MR-Guided Stereotactic Body Radiotherapy of Liver Tumors

  • STATUS
    Recruiting
  • End date
    Dec 2, 2025
  • participants needed
    46
  • sponsor
    Centre Georges Francois Leclerc
Updated on 19 February 2024
cancer
metastasis
skin cancer
stereotactic radiation therapy
hepatitis
liver cancer
liver diseases
colorectal cancer
chelates

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.

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.

Details
Condition Radiation Oncology, Radiotherapy, radiotherapeutic
Age 18-100 years
Treatment Adaptative MR-Guided Stereotactic Body Radiotherapy
Clinical Study IdentifierNCT04242342
SponsorCentre Georges Francois Leclerc
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Man or woman aged 18 or over
Performance Status 0 or 1
Primary or secondary liver tumor(s)
maximum 1 to 3 liver tumor(s) accessible to stereotaxic body radiotherapy therapy
ASAT and ALAT <3 times the upper limit of normal
Albuminemia 28g / L
Creatinine clearance> 30ml / min
signing of informed consent
Woman of childbearing age who accepts effective contraception during the course of treatment and within 3 months of treatment
Patient affiliated to a social security scheme

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
Malignant neoplasm treated with curative intent and with no known active disease 5 years before inclusion
Non-melanoma or malignant lentigo skin cancer treated adequately without signs of disease
Carcinoma in situ treated without sign of disease
Prostate carcinoma that did not require curative treatment
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.