search
Back to results

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

Primary Purpose

Digestive Neuroendocrine Tumors, Metabolic Radiotherapy, Resection

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
In111-Pentetréotide
simple monitoring without active therapy
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Digestive Neuroendocrine Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hôpital Haut Lévêque - CHU Bordeaux
  • Hôpital Beaujon
  • Hôpital R. Salengro
  • Hôpital Hôtel Dieu
  • Hôptal Cochin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

metabolic radiotherapy

No metabolic radiotherapy - simple monitoring

Arm Description

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

No metabolic radiotherapy - simple monitoring without theraoy

Outcomes

Primary Outcome Measures

relapse-free survival (RFS)

Secondary Outcome Measures

Quality of life (EORTC QLQ-C30)
At Baseline, 12, 18 et 24 weeks during therapy, then every 6 months during follow up
Tolerability
Hematological and renal tolerability
Overall survival (1)
Overall survival (2)
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.
Impact of the therapy on 1-year RFS in treatment and control group
Impact of the therapy on 5-year RFS in treatment and control group

Full Information

First Posted
June 3, 2015
Last Updated
February 26, 2019
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
search

1. Study Identification

Unique Protocol Identification Number
NCT02465112
Brief Title
Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Although the relevance of this study remains, the recruitment was too slow (4 patients in 2 years).
Study Start Date
September 2015 (undefined)
Primary Completion Date
October 11, 2018 (Actual)
Study Completion Date
October 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive Neuroendocrine Tumors, Metabolic Radiotherapy, Resection, Liver Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
metabolic radiotherapy
Arm Type
Experimental
Arm Description
In111-Pentetréotide at 12, 18 and 24 weeks after surgery,
Arm Title
No metabolic radiotherapy - simple monitoring
Arm Type
Active Comparator
Arm Description
No metabolic radiotherapy - simple monitoring without theraoy
Intervention Type
Drug
Intervention Name(s)
In111-Pentetréotide
Intervention Type
Other
Intervention Name(s)
simple monitoring without active therapy
Primary Outcome Measure Information:
Title
relapse-free survival (RFS)
Time Frame
up to 3-year
Secondary Outcome Measure Information:
Title
Quality of life (EORTC QLQ-C30)
Description
At Baseline, 12, 18 et 24 weeks during therapy, then every 6 months during follow up
Time Frame
up to 5-year
Title
Tolerability
Description
Hematological and renal tolerability
Time Frame
up to 5-year after surgery
Title
Overall survival (1)
Time Frame
up to 3-year
Title
Overall survival (2)
Time Frame
up to 5-year
Title
Identify predictive factors of RFS
Description
Predictive factor : primary tumor location, proliferation index, bilobar or unilobar invasion, number of resected tumors and intratumoral SST2 density immunohistochemical detection.
Time Frame
Up to 3-year
Title
Impact of the therapy on 1-year RFS in treatment and control group
Time Frame
Up to 1-year
Title
Impact of the therapy on 5-year RFS in treatment and control group
Time Frame
Up to 5-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachida LEBTAHI, MD
Organizational Affiliation
Hôpital Beaujon
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Haut Lévêque - CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33604
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hôpital R. Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Hôtel Dieu
City
Nantes
Country
France
Facility Name
Hôptal Cochin
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs