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

NCT02465112 | Terminated Phase 3 DMC

• 1 other identifier: TERAVECT D13-2
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 5

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.

Conditions

Digestive Neuroendocrine Tumors; Metabolic Radiotherapy; Resection; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• relapse-free survival (RFS)

  up to 3-year

Secondary Outcomes (7)

• Quality of life (EORTC QLQ-C30)

  up to 5-year

• 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

  Up to 3-year

Study Arms (2)

metabolic radiotherapy

EXPERIMENTAL

In111-Pentetréotide at 12, 18 and 24 weeks after surgery,

Drug: In111-Pentetréotide

No metabolic radiotherapy - simple monitoring

ACTIVE COMPARATOR

No metabolic radiotherapy - simple monitoring without theraoy

Other: simple monitoring without active therapy

Interventions

In111-Pentetréotide DRUG

metabolic radiotherapy

simple monitoring without active therapy OTHER

No metabolic radiotherapy - simple monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (5)

Hôpital Haut Lévêque - CHU Bordeaux

Bordeaux, 33604, France

Location

Hôpital Beaujon

Clichy, 92110, France

Location

Hôpital R. Salengro

Lille, 59037, France

Location

Hôpital Hôtel Dieu

Nantes, France

Location

Hôptal Cochin

Paris, 75014, France

Location

Study Officials

• Rachida LEBTAHI, MD

  Hôpital Beaujon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 8, 2015
• Study Start: September 1, 2015
• Primary Completion: October 11, 2018
• Study Completion: October 11, 2018
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

FR (5)