RadiotherapyRASTAFNCT04242342
Adaptative MR-Guided Stereotactic Body Radiotherapy of Liver Tumors
A study testing Adaptative MR-Guided Stereotactic Body Radiotherapy in people with Radiotherapy, run by Centre Georges Francois Leclerc at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy
- What is being tested?
- Adaptative MR-Guided Stereotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2020to 20 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Radiotherapy
- Being tested
- Adaptative MR-Guided Stereotactic Body Radiotherapy
- Keywords
- liver cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptative MR-Guided Stereotactic Body RadiotherapyRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Adaptative MR-Guided Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
local control at 2 years
lack of progression according to RECIST criteria
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start20 Jan 2020
- Primary completion20 Jan 2029 (estimated)
- Study completion20 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242342
- Sponsor's protocol ID
- RASTAF IRM
- Acronym
- RASTAF
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2020
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II of Adaptative Magnetic Resonance-Guided Stereotactic Body Radiotherapy (SBRT) for Treatment of Primary or Secondary Progressive Liver Tumors
- ClinicalTrials.gov ID
- NCT04242342
- Acronym / sponsor ID
- RASTAF / RASTAF IRM
- Conditions
- Radiotherapy
- Keywords
- liver cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 20 Jan 2029 (estimated)
- Study completion
- 20 Jan 2029 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Radiation: Adaptative MR-Guided Stereotactic Body RadiotherapyPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptative MR-Guided Stereotactic Body RadiotherapyIf 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 | Radiation | Experimental arm |
Primary outcome
local control at 2 years
Time frame: 2 years
lack of progression according to RECIST criteria
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptative MR-Guided Stereotactic Body Radiotherapy in people with Radiotherapy, run by Centre Georges Francois Leclerc at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local control at 2 years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.