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

Liver Metastases Clinical Trial

— TERAVECT  

Official title:

A Randomized Phase III of Adjuvant Targeted Radionuclide Therapy With In111-Pentetreotide in Patients With Digestive Neuroendocrine Tumors After Complete Surgical Resection of Liver Metastases.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02465112
• Other study ID #: TERAVECT D13-2
• Status: Terminated
• Phase: Phase 3
• Start date: September 2015
• Est. completion date: October 11, 2018

Study information

• Verified date: February 2019
• Source: GERCOR - Multidisciplinary Oncology Cooperative Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 11, 2018
• Est. primary completion date: October 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (ß-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).

Related Conditions & MeSH terms

• Digestive Neuroendocrine Tumors
• Liver Metastases
• Liver Neoplasms
• Metabolic Radiotherapy
• Neoplasm Metastasis
• Neuroendocrine Tumors
• Resection

Intervention

Drug:
• In111-Pentetréotide

Other:
• simple monitoring without active therapy

Locations

Country	Name	City	State
France	Hôpital Haut Lévêque - CHU Bordeaux	Bordeaux
France	Hôpital Beaujon	Clichy
France	Hôpital R. Salengro	Lille
France	Hôpital Hôtel Dieu	Nantes
France	Hôptal Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GERCOR - Multidisciplinary Oncology Cooperative Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse-free survival (RFS)		up to 3-year
Secondary	Quality of life (EORTC QLQ-C30)	At Baseline, 12, 18 et 24 weeks during therapy, then every 6 months during follow up	up to 5-year
Secondary	Tolerability	Hematological and renal tolerability	up to 5-year after surgery
Secondary	Overall survival (1)		up to 3-year
Secondary	Overall survival (2)		up to 5-year
Secondary	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.	Up to 3-year
Secondary	Impact of the therapy on 1-year RFS in treatment and control group		Up to 1-year
Secondary	Impact of the therapy on 5-year RFS in treatment and control group		Up to 5-year