Clinical trial NCT03408665: Stereotactic Body Radiation Therapy (SBRT) Efficiency and Toxicity in Liver Cancer
Official title: Phase II Study, Stratified, Non-randomized, Estimating SBRT Efficiency and Toxicity in Primary and Secondary Liver Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Liver Cancer
Liver Metastases
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Canceropôle Nord Ouest
First posted: 2018-01-24
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients will first go through an inclusion check-up consisting of:

* a clinical exam: disease history, previous treatments, weight, height, patient's performance status (ECOG) and HCC status.
* a biological test: biochemical (total bilirubin, ASAT-ALAT, LDH, albumin, alkaline phosphatases, GGT), hematological (if the patient is going to receive a fiducial), alphafoetoprotein (for HCC) and pregnancy test (if applicable)
* a tumor assessment: using a CT-scan or a MRI and using RECIST or mRECIST (if HCC), plus other morphological exams if judged useful by the investigator This check-up has to be realized within 28 days before inclusion. Then, the use of fiducial is optional.

Before the beginning of the treatment, a pre-therapeutic check-up is done:

* the inclusion check-up has to be done a second time if the treatment begins more than 28 days after the first one
* Tracking scanner.

The SBRT treatment is done in 3 to 6 times and no specific SBRT techniques are asked for, the investigator can choose according to the center habits.

After the treatment, a follow-up will be realized at 3, 6, 9, 12, 18, 24, 30 and 36 months and then once a year until the last patient included reach their 36th month of follow-up. The follow-up check-up consists of a clinical exam, biological test, tumor assessment and tolerance assessment.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Estimate the SBRT efficiency in a prospective way, in term of local progression-free survival (L-PFS) for patient treated with SBRT in the 4 considered clinical situations.
timeFrame: From baseline to 36 months following up.
measure: Describe the different SBRT techniques used in the study for liver tumor.
timeFrame: From baseline to 36 months following up.
measure: Determine the SBRT feasibility by comparison of planned SBRT to performed SBRT.
timeFrame: From baseline to 36 months following up.
measure: Estimate the SBRT efficiency in a prospective way, in term of overall survival (OS) in the 4 considered clinical situations.
timeFrame: From baseline to 36 months following up.
measure: Estimate the SBRT efficiency in a prospective way, in term of progression-free survival (PFS) in the 4 considered clinical situations.
timeFrame: From baseline to 36 months following up.
measure: Assess the immediate and delayed toxicity.
timeFrame: From baseline to 36 months following up.
measure: Estimate the quality-adjusted survival (Q-TWiST) for patients in each of the 4 considered clinical situations.
timeFrame: From baseline to 36 months following up.
measure: Estimate the proportion of patients for whom an hospitalization is required.
timeFrame: From baseline to 36 months following up.
measure: Estimate the impact of the different SBRT techniques on SBRT efficacy according to L-PFS.
timeFrame: From baseline to 36 months following up.
measure: Estimate the impact of the different SBRT techniques on SBRT efficacy according to PFS.
timeFrame: From baseline to 36 months following up.
measure: Estimate the impact of the different SBRT techniques on SBRT efficacy according to OS.
timeFrame: From baseline to 36 months following up.
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
state: Nord
city: Dechy
country: France
facility: Centre Léonard de Vinci
city: Montpellier
country: France
facility: Institut Régional du Cancer de Montpellier
city: Sarcelles
country: France
facility: Institut de Cancérologie Paris Nord
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Oscar Lambret
name: Xavier MIRABEL, MD
role: PRINCIPAL_INVESTIGATOR
References: