Informations générales (source: ClinicalTrials.gov)
Phase II Study, Stratified, Non-randomized, Estimating SBRT Efficiency and Toxicity in Primary and Secondary Liver Tumors
Interventional
N/A
Centre Oscar Lambret (Voir sur ClinicalTrials)
mars 2019
décembre 2027
18 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Léonard de Vinci - Dechy - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59020 - Lille - Nord - France | Contact (sur clinicalTrials) | ||||
| Centre Paul Strauss - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de Lorraine - 54519 - Vandœuvre-lès-Nancy - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie Paris Nord - 95200 - Sarcelles - France | Contact (sur clinicalTrials) | ||||
| Institut Régional du Cancer de Montpellier - Montpellier - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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