Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor

Phase 3

Terminated

• Conditions: Liver Metastases; Digestive Neuroendocrine Tumors; Metabolic Radiotherapy; Resection
• Interventions: Other: simple monitoring without active therapy; Drug: In111-Pentetréotide

• Registration Number: NCT02465112
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-08
• Study Start: 2015-09
• Primary Completion: 2018-10-11
• Study Completion: 2018-10-11
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No metabolic radiotherapy - simple monitoring	simple monitoring without active therapy	No metabolic radiotherapy - simple monitoring without theraoy
metabolic radiotherapy	In111-Pentetréotide	In111-Pentetréotide at 12, 18 and 24 weeks after surgery,

Primary Outcome Measures

Name	Time	Method
relapse-free survival (RFS)	up to 3-year

Secondary Outcome Measures

Name	Time	Method
Overall survival (1)	up to 3-year
Overall survival (2)	up to 5-year
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
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.
Impact of the therapy on 1-year RFS in treatment and control group	Up to 1-year

Trial Locations

Locations (5)

Hôpital Beaujon; 🇫🇷 Clichy, France

Hôptal Cochin; 🇫🇷 Paris, France

Hôpital Haut Lévêque - CHU Bordeaux; 🇫🇷 Bordeaux, France

Hôpital R. Salengro; 🇫🇷 Lille, France

Hôpital Hôtel Dieu; 🇫🇷 Nantes, France