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

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.

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 Overview

• Status: Terminated
• Conditions: Liver Metastases; Resection; Digestive Neuroendocrine Tumors; Metabolic Radiotherapy
• Intervention / Treatment: Drug: In111-Pentetréotide; Other: simple monitoring without active therapy

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33604
    • Hopital Haut Lévèque - CHU Bordeaux
  • Clichy, France, 92110
    • Hopital Beaujon
  • Lille, France, 59037
    • Hopital R. Salengro
  • Nantes, France
    • Hôpital Hotel Dieu
  • Paris, France, 75014
    • Hôptal Cochin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: metabolic radiotherapy; In111-Pentetréotide at 12, 18 and 24 weeks after surgery,	Drug: In111-Pentetréotide
Active Comparator: No metabolic radiotherapy - simple monitoring; No metabolic radiotherapy - simple monitoring without theraoy	Other: simple monitoring without active therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
relapse-free survival (RFS)	up to 3-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Tolerability	Hematological and renal tolerability	up to 5-year after surgery
Overall survival (1)		up to 3-year
Overall survival (2)		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.	Up to 3-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

Collaborators and Investigators

• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
• Investigators: Study Director: Rachida LEBTAHI, MD, Hopital Beaujon

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): October 11, 2018
• Study Completion (Actual): October 11, 2018

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms; Neuroendocrine Tumors
• Other Study ID Numbers: TERAVECT D13-2