Digestive Neuroendocrine TumorsPhase 3TERAVECTNCT02465112
Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor
A Phase 3 study testing In111-Pentetréotide and simple monitoring without active therapy in people with Digestive Neuroendocrine Tumors and Metabolic Radiotherapy, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive Neuroendocrine Tumors, Metabolic Radiotherapy, Resection
- What is being tested?
- In111-Pentetréotide and simple monitoring without active therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 5 sitesFrance
- Study dates
- Sep 2015to 11 Oct 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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)
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Haut Lévêque - CHU Bordeaux
Bordeaux, 33604
Hôpital Beaujon
Clichy, 92110
Hôpital R. Salengro
Lille, 59037
Hôpital Hôtel Dieu
Nantes
Hôptal Cochin
Paris, 75014
About this study
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.
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.
- Being tested
- In111-Pentetréotide, simple monitoring without active therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In111-PentetréotideDrug
simple monitoring without active therapyOther
| Study group | Role | What they receive |
|---|---|---|
| metabolic radiotherapy | Experimental | In111-Pentetréotide at 12, 18 and 24 weeks after surgery, Receives: Drug: In111-Pentetréotide |
| No metabolic radiotherapy - simple monitoring | Active comparator | No metabolic radiotherapy - simple monitoring without theraoy Receives: Other: simple monitoring without active therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse-free survival (RFS)
Measured: up to 3-year
Secondary outcomes (7)
Quality of life (EORTC QLQ-C30)
At Baseline, 12, 18 et 24 weeks during therapy, then every 6 months during follow up
Measured: up to 5-year
Tolerability
Hematological and renal tolerability
Measured: up to 5-year after surgery
Overall survival (1)
Measured: up to 3-year
Overall survival (2)
Measured: up to 5-year
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.
Measured: Up to 3-year
Impact of the therapy on 1-year RFS in treatment and control group
Measured: Up to 1-year
Impact of the therapy on 5-year RFS in treatment and control group
Measured: Up to 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startSep 2015
- Primary completion11 Oct 2018
- Study completion11 Oct 2018
Why it stopped: Although the relevance of this study remains, the recruitment was too slow (4 patients in 2 years).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachida LEBTAHI, MD, Study director, Hôpital Beaujon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465112
- Sponsor's protocol ID
- TERAVECT D13-2
- Acronym
- TERAVECT
- Status last verified
- Feb 2019
- First submitted
- 3 Jun 2015
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02465112
- Acronym / sponsor ID
- TERAVECT / TERAVECT D13-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Although the relevance of this study remains, the recruitment was too slow (4 patients in 2 years).
- Enrolment
- 4 participants (actual)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metabolic radiotherapy | Experimental | Drug: In111-PentetréotideIn111-Pentetréotide at 12, 18 and 24 weeks after surgery, |
| No metabolic radiotherapy - simple monitoring | Active comparator | Other: simple monitoring without active therapyNo metabolic radiotherapy - simple monitoring without theraoy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In111-Pentetréotide | Drug | metabolic radiotherapy |
| simple monitoring without active therapy | Other | No metabolic radiotherapy - simple monitoring |
Primary outcome
relapse-free survival (RFS)
Time frame: up to 3-year
7 secondary outcomes
Quality of life (EORTC QLQ-C30)
Time frame: up to 5-year
Tolerability
Time frame: up to 5-year after surgery
Overall survival (1)
Time frame: up to 3-year
Overall survival (2)
Time frame: up to 5-year
Identify predictive factors of RFS
Time frame: Up to 3-year
Impact of the therapy on 1-year RFS in treatment and control group
Time frame: Up to 1-year
Impact of the therapy on 5-year RFS in treatment and control group
Time frame: Up to 5-year
Results and safety
The study was stopped early (reason given: Although the relevance of this study remains, the recruitment was too slow (4 patients in 2 years).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachida LEBTAHI, MD study director
Hôpital Beaujon
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing In111-Pentetréotide and simple monitoring without active therapy in people with Digestive Neuroendocrine Tumors and Metabolic Radiotherapy, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Although the relevance of this study remains, the recruitment was too slow (4 patients in 2 years).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse-free survival (RFS) (time frame: up to 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.