Adaptative MR-Guided Stereotactic Body Radiotherapy of Liver Tumors

NCT04242342 | Active Not Recruiting

• 1 other identifier: RASTAF IRM
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiotherapy

Keywords

liver cancer

Outcome Measures

Primary Outcomes (1)

• local control at 2 years

  lack of progression according to RECIST criteria

  2 years

Study Arms (1)

Experimental arm

EXPERIMENTAL

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

Interventions

Adaptative MR-Guided Stereotactic Body Radiotherapy RADIATION

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

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges François Leclerc

Dijon, 21000, France

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: January 20, 2020
• Primary Completion (Estimated): January 20, 2029
• Study Completion (Estimated): January 20, 2029
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

FR (1)