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

Primary Purpose

Radiotherapy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adaptative MR-Guided Stereotactic Body Radiotherapy
Sponsored by
Centre Georges Francois Leclerc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiotherapy focused on measuring liver cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Georges François LeclercRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental arm

Arm Description

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.

Outcomes

Primary Outcome Measures

local control at 2 years
lack of progression according to RECIST criteria

Secondary Outcome Measures

Full Information

First Posted
January 23, 2020
Last Updated
October 16, 2023
Sponsor
Centre Georges Francois Leclerc
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1. Study Identification

Unique Protocol Identification Number
NCT04242342
Brief Title
Adaptative MR-Guided Stereotactic Body Radiotherapy of Liver Tumors
Acronym
RASTAF
Official Title
Phase II of Adaptative Magnetic Resonance-Guided Stereotactic Body Radiotherapy (SBRT) for Treatment of Primary or Secondary Progressive Liver Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
January 20, 2024 (Anticipated)
Study Completion Date
January 20, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiotherapy
Keywords
liver cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Adaptative MR-Guided Stereotactic Body Radiotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
local control at 2 years
Description
lack of progression according to RECIST criteria
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magali Rouffiac Thouant
Phone
03 80 73 75 18
Email
mrouffiac@cgfl.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emlie REDERSTORFF
Phone
03 45 34 81 16
Email
erederstorff@cgfl.fr
Facility Information:
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magalie ROUFFIAC
Phone
03 45 34 81 06
Email
mrouffiac@cgfl.fr
First Name & Middle Initial & Last Name & Degree
Emilie Rederstorff
Phone
03 45 34 81 16
Email
erederstorff@cgfl.fr

12. IPD Sharing Statement

Learn more about this trial

Adaptative MR-Guided Stereotactic Body Radiotherapy of Liver Tumors

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