Digestive Neuroendocrine Tumors, Liver Metastases, Metabolic Radiotherapy, Resection
Conditions
Brief summary
TERAVECT is a phase III randomized study of patients with digestive neuroendocrine tumors after complete surgical resection of liver metastases treated with In111-Pentetreotide-based adjuvant radiotherapy. In this study, targeted radionuclide therapy is used at an earlier stage of the disease.The objective is to target residual tumor cells and/or micrometastases which escaped surgical resection. Given the poor prognosis associated with recurrence, this treatment should prevent relapse.
Interventions
DRUGIn111-Pentetréotide
OTHERsimple monitoring without active therapy
Sponsors
GERCOR - Multidisciplinary Oncology Cooperative Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent, * Age ≥ 18 years, * Patients with well differenciated digestive neuroendocrine tumors and liver metastases, for whom a complete surgical resection of liver metastases and of the primary tumor was performed, in 1 or 2 times, * Immunohistochemical confirmation of neuroendocrine tumors with WHO 2010 grading specification and Ki67 determined of the surgical specimen, * ECOG Performance Status (PS) 0-1, * Adequate hematological status: Platelets \>100000/mm3, Hemoglobin \>10g/dL, * Adequate Clearance Creatinine \>60 mL/min, * Adequate liver function: Total Serum Bilirubin \<1.5x upper limit of normal (ULN), transaminases \<3 x ULN, * Grade of In111-Pentetreotide uptake ≥ 2 (scored according to the Krenning et al scale.: more intense than physiological liver uptake), * Treatment started within 14 weeks after surgical resection, * Men and women are required to use adequate birth control measures during the course of the study and for a period of 12 months after the last administration of study drug. Female patients with childbearing potential must have a negative serum pregnant test (β-HCG) within 7 days before starting study treatment, * Life expectancy \>6 months * Registration with the National Health Care System (CMU included for France)
Exclusion criteria
* History of previous or second cancer or progressive cancer occurring within 5 years prior to inclusion, except for basal cell or squamous cell carcinoma, * Patients with known sensibility or hypersensibility to In111- Pentetreotide or any component of the treatment drug, * Pregnant or breast-feeding women without adequate birth control measures, * Patient with known medical history of psychological or psychiatric disorders that may affect patient participation in study due to lack of cooperation or loss of autonomy preventing hospitalization and initiation of study treatment (in good radiation protection conditions), * Treatment with any investigational drug within 28 days prior to study entry, * Patient protected by law (tutelage or guardianship).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relapse-free survival (RFS) | up to 3-year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (EORTC QLQ-C30) | up to 5-year | At Baseline, 12, 18 et 24 weeks during therapy, then every 6 months during follow up |
| Tolerability | up to 5-year after surgery | Hematological and renal tolerability |
| Overall survival (1) | up to 3-year | — |
| Overall survival (2) | up to 5-year | — |
| Impact of the therapy on 1-year RFS in treatment and control group | Up to 1-year | — |
| Impact of the therapy on 5-year RFS in treatment and control group | Up to 5-year | — |
| Identify predictive factors of RFS | Up to 3-year | Predictive factor : primary tumor location, proliferation index, bilobar or unilobar invasion, number of resected tumors and intratumoral SST2 density immunohistochemical detection. |
Countries
France
Outcome results
None listed