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

February 26, 2019 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Hôtel Dieu
      • Paris, France, 75014
        • Hôptal Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
relapse-free survival (RFS)
Time Frame: up to 3-year
up to 3-year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life (EORTC QLQ-C30)
Time Frame: up to 5-year
At Baseline, 12, 18 et 24 weeks during therapy, then every 6 months during follow up
up to 5-year
Tolerability
Time Frame: up to 5-year after surgery
Hematological and renal tolerability
up to 5-year after surgery
Overall survival (1)
Time Frame: up to 3-year
up to 3-year
Overall survival (2)
Time Frame: up to 5-year
up to 5-year
Identify predictive factors of RFS
Time Frame: Up to 3-year
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
Time Frame: Up to 1-year
Up to 1-year
Impact of the therapy on 5-year RFS in treatment and control group
Time Frame: Up to 5-year
Up to 5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rachida LEBTAHI, MD, Hopital Beaujon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TERAVECT D13-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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