NCT04242342Active, not recruiting
Adaptative MR-Guided Stereotactic Body Radiotherapy of Liver Tumors
Phase II of Adaptative Magnetic Resonance-Guided Stereotactic Body Radiotherapy (SBRT) for Treatment of Primary or Secondary Progressive Liver Tumors
Source: ClinicalTrials.gov · Last updated 12 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 23 Jan 2020
- Start date
- 20 Jan 2020
- Primary completion date
- 20 Jan 2029
- Lead sponsor
- Centre Georges Francois Leclerc
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04242342
What you commit to
- Study type: Interventional
- Planned participants: 46
- From 20 Jan 2020 to the primary completion date, 20 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient previously irradiated in the planned treatment area.
- 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.
Other illness
- Known hypersensitivity to gadolinium or other gadolinium chelates.
Age
- 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.
Other
- MRI contraindication
- Pregnant or breastfeeding woman.
- Patient with decompensated liver cirrhosis or cirrhosis\> Child B7
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.