Status:
ACTIVE_NOT_RECRUITING
Stereotactic Body Radiation Therapy (SBRT) Efficiency and Toxicity in Liver Cancer
Lead Sponsor:
Centre Oscar Lambret
Collaborating Sponsors:
Canceropôle Nord Ouest
Conditions:
Liver Cancer
Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 bi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT03408665
Start Date
March 13 2019
End Date
December 1 2027
Last Update
February 13 2025
Active Locations (7)
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1
Centre Oscar Lambret
Lille, Nord, France, 59020
2
Centre Léonard de Vinci
Dechy, France
3
Institut Régional du Cancer de Montpellier
Montpellier, France
4
Institut de Cancérologie Paris Nord
Sarcelles, France, 95200