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

NCT ID: NCT02465112

Last Updated: 2019-02-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-10-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

metabolic radiotherapy

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

Group Type: EXPERIMENTAL

In111-Pentetréotide

Intervention Type: DRUG

No metabolic radiotherapy - simple monitoring

No metabolic radiotherapy - simple monitoring without theraoy

Group Type: ACTIVE_COMPARATOR

simple monitoring without active therapy

Intervention Type: OTHER

Interventions

In111-Pentetréotide

Intervention Type: DRUG

simple monitoring without active therapy

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachida LEBTAHI, MD

Role: STUDY_DIRECTOR

Hôpital Beaujon

Locations

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

Countries

France

Other Identifiers

TERAVECT D13-2

Identifier Type: -

Identifier Source: org_study_id