Stereotactic Body Radiation Therapy (SBRT) Efficiency and Toxicity in Liver Cancer (NCT03408665) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Stereotactic Body Radiation Therapy (SBRT) Efficiency and Toxicity in Liver Cancer
France280 participantsStarted 2019-03-13
Plain-language summary
Intervention research involving the human person, phase II, prospective, multicentric, non-randomized and multi-cohort study. The eligibility criteria are broad, on purpose, so every patient, able to be treated by SBRT and unable to participate in another trial (non eligible patient or non included centers), can be included in this national study, in a prospective way.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years old
* With primary or secondary liver tumor and matching one of the following situations:
* Liver Metastasis (LM): anatomopathologic diagnosis of the primary tumor
* Hepatocellular Carcinoma (HCC): diagnosis achieved through biopsy or through non-invasive methods approved by AASLD criteria (Bruix, 2011)
* Cholangiocarcinoma (CC): diagnosis achieved through biopsy
* Other primitive hepatic tumor achieved through biopsy
* Meet the requirements for SBRT treatment:
* Liver Metastasis (LM): oligometastatic disease
* Hepatocellular Carcinoma (HCC): non eligible lesion to curative surgery
* Cholangiocarcinoma (CC): nodular lesion
* Other primitive hepatic tumor: non eligible lesion to curative surgery
* Able to receive a SBRT treatment according to the multidisciplinary consultation meeting
* Tumor assessable with CT-scan or MRI according to mRECIST in HCC or Recist 1.1 in other situations
* Affiliation to the National Social Security System
* With informed and signed consent
Exclusion Criteria:
* Eligibility to a curative surgery according to the multidisciplinary consultation meeting
* Contraindication to SBRT (especially Cirrhose Child C)
* Pregnant or breastfeeding women
* Patient Under guardianship or tutorship
* Impossibility to submit at the study procedures due to geographic, social or mental reasons
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SBRT efficiency in term of L-PFS for patient who are to be treated with SBRT in patients with primitive hepatic tumor of hepatic metastatis
Timeframe: From baseline to 36 months following up.