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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Hôpital Haut Lévêque - CHU Bordeaux
Bordeaux, France
Hôpital Beaujon
Clichy, France
Hôpital R. Salengro
Lille, France
Hôpital Hôtel Dieu
Nantes, France
Hôptal Cochin
Paris, France
relapse-free survival (RFS)
Time frame: up to 3-year
Quality of life (EORTC QLQ-C30)
At Baseline, 12, 18 et 24 weeks during therapy, then every 6 months during follow up
Time frame: up to 5-year
Tolerability
Hematological and renal tolerability
Time frame: up to 5-year after surgery
Overall survival (1)
Time frame: up to 3-year
Overall survival (2)
Time frame: up to 5-year
Identify predictive factors of RFS
Predictive factor : primary tumor location, proliferation index, bilobar or unilobar invasion, number of resected tumors and intratumoral SST2 density immunohistochemical detection.
Time frame: Up to 3-year
Impact of the therapy on 1-year RFS in treatment and control group
Time frame: Up to 1-year
Impact of the therapy on 5-year RFS in treatment and control group
Time frame: Up to 5-year
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