Clinical trial NCT02465112: Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Digestive Neuroendocrine Tumors
Metabolic Radiotherapy
Resection
Liver Metastases
Lead sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: relapse-free survival (RFS)
timeFrame: up to 3-year
Secondary outcomes:
measure: Quality of life (EORTC QLQ-C30)
timeFrame: up to 5-year
measure: Tolerability
timeFrame: up to 5-year after surgery
measure: Overall survival (1)
timeFrame: up to 3-year
measure: Overall survival (2)
timeFrame: up to 5-year
measure: Identify predictive factors of RFS
timeFrame: Up to 3-year
measure: Impact of the therapy on 1-year RFS in treatment and control group
timeFrame: Up to 1-year
measure: Impact of the therapy on 5-year RFS in treatment and control group
timeFrame: Up to 5-year
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Haut Lévêque - CHU Bordeaux
city: Clichy
country: France
facility: Hôpital Beaujon
city: Lille
country: France
facility: Hôpital R. Salengro
city: Nantes
country: France
facility: Hôpital Hôtel Dieu
city: Paris
country: France
facility: Hôptal Cochin
Study officials:
affiliation: Hôpital Beaujon
name: Rachida LEBTAHI, MD
role: STUDY_DIRECTOR
References: