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

Phase II of Adaptative Magnetic Resonance-Guided Stereotactic Body Radiotherapy (SBRT) for Treatment of Primary or Secondary Progressive Liver Tumors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Radiotherapy
• Intervention / Treatment: Radiation: Adaptative MR-Guided Stereotactic Body 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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magali Rouffiac Thouant; Phone Number: 03 80 73 75 18; Email: mrouffiac@cgfl.fr
• Study Contact Backup: Name: Emlie REDERSTORFF; Phone Number: 03 45 34 81 16; Email: erederstorff@cgfl.fr

Study Locations

• France
  • Dijon, France, 21000
    • Centre Georges Francois Leclerc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local control at 2 years	lack of progression according to RECIST criteria	2 years

Collaborators and Investigators

• Sponsor: Centre Georges Francois Leclerc

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Estimated): January 20, 2029
• Study Completion (Estimated): January 20, 2029

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: liver cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: RASTAF IRM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No