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Adaptative MR-Guided Stereotactic Body Radiotherapy of Liver Tumors (RASTAF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242342
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Radiotherapy Radiation: Adaptative MR-Guided Stereotactic Body Radiotherapy Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arms and Interventions
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Arm Intervention/treatment
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:

  • 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


Outcome Measures
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Primary Outcome Measures :
  1. local control at 2 years [ Time Frame: 2 years ]
    lack of progression according to RECIST criteria


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. MRI contraindication
  2. Pregnant or breastfeeding woman.
  3. Patient with decompensated liver cirrhosis or cirrhosis> Child B7
  4. Patient previously irradiated in the planned treatment area.
  5. Refusal of patient's consent.
  6. Patient unable to give his consent, under guardianship or unable to submit to the treatment protocol or protocol follow-up.

  7. 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.
  8. Known hypersensitivity to gadolinium or other gadolinium chelates.
  9. 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Magali Rouffiac Thouant 03 80 73 75 18 mrouffiac@cgfl.fr
Contact: Emlie REDERSTORFF 03 45 34 81 16 erederstorff@cgfl.fr

Locations
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France
Centre Georges François Leclerc Recruiting
Dijon, France, 21000
Contact: Magalie ROUFFIAC    03 45 34 81 06    mrouffiac@cgfl.fr   
Contact: Emilie Rederstorff    03 45 34 81 16    erederstorff@cgfl.fr   
Sponsors and Collaborators
Centre Georges Francois Leclerc
More Information
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Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT04242342    
Other Study ID Numbers: RASTAF IRM
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Georges Francois Leclerc:
liver cancer
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases