Neuroendocrine TumorsPhase 2LUNETNCT02489604
Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors
A Phase 2 study testing 177Lu-DOTATATE 25.9 GBq activity and 177Lu-DOTATATE 18.5 GBq activity in people with Neuroendocrine Tumors, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
Trial summary
This is a randomized phase II non-comparative study. Patients with gastroenteropancreatic Neuroendocrine tumour (GEP-NET) G1-G2 with progressive disease, SSR positive and FDG negative will be enrolled in the study and will be randomly assigned to 2 different dosages (total activity of 25.9 GBq and total activity of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 177Lu-DOTATATE 25.9 GBq activity and 177Lu-DOTATATE 18.5 GBq activity
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2013to Jan 2024
- Phase
- Phase 2
- 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
- Patients must have histologically or cytologically confirmation of GEP -NETand Ki 67 index <= 20%.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.criteria)
- Advanced GEP-NET are eligible; patients must have progressive disease based on RECIST 1.1. criteria
- Diagnostic OctreoScan and/or PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour
- FDG PET negative (SUV less than 2.5)
- Concomitant somatostatin analogs assumption is allowed
Show all 11Show fewer
- Life expectancy greater than 6 months.
- ECOG performance status <2
- Adequate haematological, liver and renal function: haemoglobin >= 9 g/dL, absolute neutrophil count (ANC) >= 1.5 x 109 /L, platelets >= 100 x 109 /L, bilirubin ≤1.5 X upper normal limit (UNL) , Alanine transaminase (ALT) <2.5 X UNL (< 5 X UNL in presence of liver metastases), creatinine < 2 mg/dL.
- If female of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug. Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment.
- Participant is willing and able to give informed consent for participation in the study.
Who cannot join
- Ki 67 index > 20 %
- FDG PET positive at least in one documented lesion with a SUV more than 2.5
- Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy).
- Patients treated with previous radiometabolic therapy with an adsorbed dose to the kidney more than 25 Gy and 1,5 Gy for the bone marrow.
- All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade <= 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE)
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peptide Receptor Radionuclide Therapy (PRRT) with Radiolabelled Somatostatin Analogue 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors, 18F-2-fluoro-2-deoxy-D-glucose (FDG)-PET Negative Patients: a Prospective Phase II Randomized Study
This is a randomized phase II non-comparative study. Patients with gastroenteropancreatic Neuroendocrine tumour (GEP-NET) G1-G2 with progressive disease, SSR positive and FDG negative will be enrolled in the study and will be randomly assigned to 2 different dosages (total activity of 25.9 GBq and total activity of 18.5 GBq).
Read the detailed description
This is a randomized phase II non-comparative study. Patients with GEP-NET G1-G2 with progressive disease, somatostatin receptor (SSR) positive and FDG negative will be enrolled in the study and will be randomly assigned to 2 different dosages (total activity of 25.9 GBq and total activity of 18.5 GBq). The two levels of dosages are:
- Total activity of 25.9 GBq 100 mCi for 7 cycles at 6 ± 2 weeks (700 mCi)
- Total activity of 18.5 GBq 100 mCi for 5 cycles at 6 ± 2 weeks (500 mCi) The randomized study design allows for two active treatments to be evaluated in a comparable patient population. The estimates of primary objectives can be evaluated for each regimen separately by a Bryant and Day design. While the sample size is not powered for statistical test of a specific hypothesis for comparison between groups, this study design allows the unbiased collection of activity and safety in these two regimens in the same population, which will be useful for planning future studies.
- Conditions
- Neuroendocrine Tumors
- Being tested
- 177Lu-DOTATATE 25.9 GBq activity, 177Lu-DOTATATE 18.5 GBq activity
- Keywords
- neuroendocrine tumors
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-DOTATATE 25.9 GBq activityDrug
Also called 177Lu-DOTATATE
177Lu-DOTATATE will be administered in a 30 minutes infusion. Total activity of 25.9 GBq 100 mCi for 7 cycles every 6 ± 2 weeks (700 mCi)
177Lu-DOTATATE 18.5 GBq activityDrug
Also called 177Lu-DOTATATE
177Lu-DOTATATE will be administered in a 30 minutes infusion Total activity of 18.5 GBq 100 mCi for 5 cycles , every 6 ± 2 weeks (500 mCi)
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-DOTATATE 25.9 GBq activity | Experimental | 177Lu-DOTATATE 25.9 GBq activity. Total activity of 25.9 GBq 100 mCi for 7 cycles every 6 ± 2 weeks (700 mCi) Receives: Drug: 177Lu-DOTATATE 25.9 GBq activity |
| 177Lu-DOTATATE 18.5 GBq activity | Experimental | 177Lu-DOTATATE 18.5 GBq activity. Total activity of 18.5 GBq 100 mCi for 5 cycles, every 6 ± 2 weeks (500 mCi) Receives: Drug: 177Lu-DOTATATE 18.5 GBq activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (DCR)
the complete response rate plus the partial response rate plus the rate of patients with stable disease for at least 12 months from therapy start on patient population randomly assigned to two different scheme of therapy
Measured: up to 7 years
Acute toxicity evaluated according to version 4.0 CTCAE
The co-primary objective is the acute toxicity evaluated according to version 4.0 CTCAE
Measured: The evaluation of the acute toxicity starts from the 1st treatment until 30 days after the last treatment cycle, up to 60 wks for each patient
Secondary outcomes (3)
Progression free survival
the time from the start treatment date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.
Measured: up to 7 years
Overall survival
Overall survival is defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.
Measured: up to 7 years
Late toxicity evaluated according to version 4.0 CTCAE
late toxicity will be evaluated during the whole study period according to version 4.0 CTCAE
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startDec 2013
- Primary completionJan 2024
- Study completionJan 2024
Why it stopped: Enrollment target not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maddalena Sansovini, MD, Principal investigator, IRST IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489604
- Sponsor's protocol ID
- IRST100.11
- Acronym
- LUNET
- Status last verified
- Jan 2025
- First submitted
- 16 Jun 2015
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peptide Receptor Radionuclide Therapy (PRRT) with Radiolabelled Somatostatin Analogue 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors, 18F-2-fluoro-2-deoxy-D-glucose (FDG)-PET Negative Patients: a Prospective Phase II Randomized Study
- ClinicalTrials.gov ID
- NCT02489604
- Acronym / sponsor ID
- LUNET / IRST100.11
- Conditions
- Neuroendocrine Tumors
- Keywords
- neuroendocrine tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment target not reached
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jan 2024 (actual)
- Study completion
- Jan 2024 (actual)
- First posted
- 3 Jul 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.
This is a randomized phase II non-comparative study. Patients with gastroenteropancreatic Neuroendocrine tumour (GEP-NET) G1-G2 with progressive disease, SSR positive and FDG negative will be enrolled in the study and will be randomly assigned to 2 different dosages (total activity of 25.9 GBq and total activity of 18.5 GBq).
Detailed description
This is a randomized phase II non-comparative study. Patients with GEP-NET G1-G2 with progressive disease, somatostatin receptor (SSR) positive and FDG negative will be enrolled in the study and will be randomly assigned to 2 different dosages (total activity of 25.9 GBq and total activity of 18.5 GBq). The two levels of dosages are:
- Total activity of 25.9 GBq 100 mCi for 7 cycles at 6 ± 2 weeks (700 mCi)
- Total activity of 18.5 GBq 100 mCi for 5 cycles at 6 ± 2 weeks (500 mCi) The randomized study design allows for two active treatments to be evaluated in a comparable patient population. The estimates of primary objectives can be evaluated for each regimen separately by a Bryant and Day design. While the sample size is not powered for statistical test of a specific hypothesis for comparison between groups, this study design allows the unbiased collection of activity and safety in these two regimens in the same population, which will be useful for planning future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 177Lu-DOTATATE 25.9 GBq activity | Experimental | Drug: 177Lu-DOTATATE 25.9 GBq activity177Lu-DOTATATE 25.9 GBq activity. Total activity of 25.9 GBq 100 mCi for 7 cycles every 6 ± 2 weeks (700 mCi) |
| 177Lu-DOTATATE 18.5 GBq activity | Experimental | Drug: 177Lu-DOTATATE 18.5 GBq activity177Lu-DOTATATE 18.5 GBq activity. Total activity of 18.5 GBq 100 mCi for 5 cycles, every 6 ± 2 weeks (500 mCi) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have histologically or cytologically confirmation of GEP -NETand Ki 67 index <= 20%.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.criteria)
- Advanced GEP-NET are eligible; patients must have progressive disease based on RECIST 1.1. criteria
- Diagnostic OctreoScan and/or PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour
- FDG PET negative (SUV less than 2.5)
Key exclusion criteria (8 listed)
- Ki 67 index > 20 %
- FDG PET positive at least in one documented lesion with a SUV more than 2.5
- Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy).
- Patients treated with previous radiometabolic therapy with an adsorbed dose to the kidney more than 25 Gy and 1,5 Gy for the bone marrow.
- All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade <= 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE)
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 |
|---|---|---|
| 177Lu-DOTATATE 25.9 GBq activityAlso: 177Lu-DOTATATE177Lu-DOTATATE will be administered in a 30 minutes infusion. Total activity of 25.9 GBq 100 mCi for 7 cycles every 6 ± 2 weeks (700 mCi) | Drug | 177Lu-DOTATATE 25.9 GBq activity |
| 177Lu-DOTATATE 18.5 GBq activityAlso: 177Lu-DOTATATE177Lu-DOTATATE will be administered in a 30 minutes infusion Total activity of 18.5 GBq 100 mCi for 5 cycles , every 6 ± 2 weeks (500 mCi) | Drug | 177Lu-DOTATATE 18.5 GBq activity |
Primary outcome
Disease control rate (DCR)
Time frame: up to 7 years
the complete response rate plus the partial response rate plus the rate of patients with stable disease for at least 12 months from therapy start on patient population randomly assigned to two different scheme of therapy
Acute toxicity evaluated according to version 4.0 CTCAE
Time frame: The evaluation of the acute toxicity starts from the 1st treatment until 30 days after the last treatment cycle, up to 60 wks for each patient
The co-primary objective is the acute toxicity evaluated according to version 4.0 CTCAE
3 secondary outcomes
Progression free survival
Time frame: up to 7 years
Overall survival
Time frame: up to 7 years
Late toxicity evaluated according to version 4.0 CTCAE
Time frame: up to 7 years
Results and safety
The study was stopped early (reason given: Enrollment target not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
Related trials for Neuroendocrine Tumors
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Active, not recruitingPhase 1/2
A Study of ST-1898 for Unresectable or Metastatic Melanoma
Unresectable or Metastatic Melanoma
RecruitingObservational study
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
Pheochromocytoma, Paraganglioma
RecruitingPhase 2
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma
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.
Maddalena Sansovini, MD principal investigator
IRST IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 177Lu-DOTATATE 25.9 GBq activity and 177Lu-DOTATATE 18.5 GBq activity in people with Neuroendocrine Tumors, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
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 11 inclusion and 8 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 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Enrollment target not reached). 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?
Disease control rate (DCR) (time frame: up to 7 years). The study lists 2 primary outcomes in all. 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 13 Jan 2025.