Neuroendocrine TumorsPhase 2P-PRRTNCT02754297
Personalized PRRT of Neuroendocrine Tumors
A Phase 2 study testing 177Lu-Octreotate in people with Neuroendocrine Tumors and Carcinoid Tumor, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
In this study, peptide receptor radionuclide therapy (PRRT) with 177Lu-Octreotate (LuTate) will be personalized, i.e. administered activity of LuTate will be tailored for each patient to maximize absorbed radiation dose to tumor, while limiting that to healthy organs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Carcinoid Tumor, Carcinoma, Neuroendocrine
- What is being tested?
- 177Lu-Octreotate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteCanada
- Study dates
- 12 Apr 2016to 12 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patient suffering from a progressive and/or symptomatic NET (any site);
- Patient ineligible to, or refusing a potentially curative treatment such as surgical resection;
- Patient who did not respond, is intolerant or refuses other indicated and available palliative treatments;
- Demonstration of overexpression of somatostatin receptor by tumor lesions by scintigraphic imaging (Octreoscan or 68Ga positron emission tomography.
Who cannot join
- Pregnancy;
- Breastfeeding;.
- Very limited survival prognosis (i.e. less than a few weeks, because of the NET disease or any other condition) or Eastern Cooperative Oncology Group (ECOG) 4 performance status;
- Inability to obtain informed consent of the participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Peptide Receptor Radionuclide Therapy of Neuroendocrine Tumors: A Phase 2 Study
In this study, peptide receptor radionuclide therapy (PRRT) with 177Lu-Octreotate (LuTate) will be personalized, i.e. administered activity of LuTate will be tailored for each patient to maximize absorbed radiation dose to tumor, while limiting that to healthy organs.
The purpose of this study is to:
Read more
- Assess the objective (radiological), symptomatic and biochemical response rates following an induction course of personalized PRRT;
- Assess the overall, the disease-specific, and the progression-free survival following P-PRRT;
- Correlate therapeutic response and survival with tumor absorbed radiation dose;
- Evaluate the acute, subacute and chronic adverse events following P-PRRT;
- Correlate toxicity (i.e. occurence and severity of adverse events) with absorbed radiation doses to organs at risk;
- Optimize the quantitative SPECT imaging-based dosimetry methods in a subset of 20 patients (sub-study funded by the Canadian Institutes of Health Research).
This study also has a compassionate purpose, which is to provide access to PRRT to patients.
Read the detailed description
A prospective, single-center, non-comparative, open phase 2 study. In this study, personalized peptide receptor radionuclide therapy (P-PRRT) with 177Lu-Octreotate (LuTate) will be administered to patients with progressive and/or symptomatic inoperable neuroendocrine tumors (NET) of any origin expressing the somatostatin receptor.
The primary objective to assess the objective response rate at 3 months following a four-cycle induction course of P-PRRT will be assessed for at least the first 85 participants.
This study as a compassionate aim to provide access to personalized PRRT patients at CHU de Québec - Université Laval center, and therefore this study has no pre-determined recruitment period duration or limited number of participants, and may remain open as long as necessary to fulfill this aim.
The study will continue until all participants have completed a minimum follow-up of 5 years. Interim analyses will be conducted annually.
- Being tested
- 177Lu-Octreotate
- Keywords
- Neuroendocrine tumors, Personalized, Peptide receptor radionuclide therapy, PRRT, 177Lu-DOTATATE, 177Lu-octreotate
- Medical subject headings
- Neuroendocrine Tumors, Carcinoid Tumor, Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-OctreotateDrug
Also called LuTate, 177Lu-[DOTA0,Tyr3]octreotate, 177Lu-DOTATATE
- The induction course will consist in 4 cycles at 8-10 weeks intervals.
- Concomitant amino acids will be administered for renal protection.
- Intra-arterial LuTate administration will be allowed in suitable cases.
- Dosimetry will be based on quantitative SPECT/CT imaging.
- In patients with hormonal symptoms, somatostatine analogues can be given between P-PRRT cycles.
| Study group | Role | What they receive |
|---|---|---|
| Personalized PRRT (P-PRRT) | Experimental | 177Lu-Octreotate (LuTate) P-PRRT will be administered as follows:
* Renal absorbed radiation dose will be prescribed for the 4-cycle induction course (23 Gy) and for each subsequent cycle (6 Gy), with a reduction in cases of impaired renal or bone marrow function, or significant toxicity from prior cycles.
* The personalized activity to be administered at each cycle will be derived from renal dose per unit of injected activity that is predicted by patient characteristics or renal dose delivered during prior cycle(s).
* Participants responding to the induction course of P-PRRT will be eligible to receive additional consolidation and/or maintenance cycles.
* Participants with prior PRRT exposure outside the trial may receive less induction cycles, or only consolidation/maintenance cycle(s). Receives: Drug: 177Lu-Octreotate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Primary efficacy endpoint is the objective response rate on contrast-enhanced CT (or MRI) by RECIST criteria (and secondarily by South Western Oncology Group (SWOG) criteria) at 3 months after the 4th induction cycle of P-PRRT, in comparison to pre-treatment scan (within 3 months before commencing P-PRRT).
Measured: 3 months after induction course
Secondary outcomes (6)
Progression-free survival (PFS)
Progression of disease is defined as the time from first cycle to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria.
Measured: Time from first cycle to date of disease progression or death, reported up to 5 years after accrual closure
Overall survival (OS)
Measured: Time from first cycle to date of death, reported up to 5 years after accrual closure
Symptomatic response rate
Proportion of participants with improved, stable or worsened NET-related symptoms (frequency and severity), based on participant interviews at baseline and 3 months after completion of induction course.
Measured: 3 months after induction course
Quality of life response
Proportion of participants with improved, stable or worsened quality of life score by EORTC quality of life questionnaires QLQ-C30 and QLQ-GI.NET21, administered at baseline and 3 months after induction course.
Measured: 3 months after induction course
Biochemical response
Proportion of participants with improved (decreased by 25% or more), stable or worsened (increased by 25% or more) Chromogranin-A serum levels performed at baseline and 3 months after induction course.
Measured: 3 months after induction course
Safety determined by type, frequency and severity of adverse events per CTCAE version 4.03 and type, frequency and severity of laboratory toxicities per CTCAE version 4.03
Measured: From the first treatment cycle administration until 5 years after accrual closure or death, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start12 Apr 2016
- Primary completion12 Apr 2025 (estimated)
- Study completion12 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Mathieu Beauregard, MD,MSc,FRCPC, Principal investigator, CHU de Québec - Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754297
- Sponsor's protocol ID
- A14-11-2181
- Acronym
- P-PRRT
- Status last verified
- Aug 2024
- First submitted
- 10 Mar 2016
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Del Prete M, Buteau FA, Arsenault F, Saighi N, Bouchard LO, Beaulieu A, Beauregard JM. Personalized 177Lu-octreotate peptide receptor radionuclide therapy of neuroendocrine tumours: initial results from the P-PRRT trial. Eur J Nucl Med Mol Imaging. 2019 Mar;46(3):728-742. doi: 10.1007/s00259-018-4209-7. Epub 2018 Nov 30.
PubMed 30506283
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Peptide Receptor Radionuclide Therapy of Neuroendocrine Tumors: A Phase 2 Study
- ClinicalTrials.gov ID
- NCT02754297
- Acronym / sponsor ID
- P-PRRT / A14-11-2181
- Keywords
- Neuroendocrine tumors, Personalized, Peptide receptor radionuclide therapy, PRRT, 177Lu-DOTATATE, 177Lu-octreotate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 275 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 12 Apr 2025 (estimated)
- Study completion
- 12 Apr 2029 (estimated)
- First posted
- 28 Apr 2016 (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.
In this study, peptide receptor radionuclide therapy (PRRT) with 177Lu-Octreotate (LuTate) will be personalized, i.e. administered activity of LuTate will be tailored for each patient to maximize absorbed radiation dose to tumor, while limiting that to healthy organs.
The purpose of this study is to:
- Assess the objective (radiological), symptomatic and biochemical response rates following an induction course of personalized PRRT;
- Assess the overall, the disease-specific, and the progression-free survival following P-PRRT;
- Correlate therapeutic response and survival with tumor absorbed radiation dose;
- Evaluate the acute, subacute and chronic adverse events following P-PRRT;
- Correlate toxicity (i.e. occurence and severity of adverse events) with absorbed radiation doses to organs at risk;
- Optimize the quantitative SPECT imaging-based dosimetry methods in a subset of 20 patients (sub-study funded by the Canadian Institutes of Health Research).
This study also has a compassionate purpose, which is to provide access to PRRT to patients.
Detailed description
A prospective, single-center, non-comparative, open phase 2 study. In this study, personalized peptide receptor radionuclide therapy (P-PRRT) with 177Lu-Octreotate (LuTate) will be administered to patients with progressive and/or symptomatic inoperable neuroendocrine tumors (NET) of any origin expressing the somatostatin receptor.
The primary objective to assess the objective response rate at 3 months following a four-cycle induction course of P-PRRT will be assessed for at least the first 85 participants.
This study as a compassionate aim to provide access to personalized PRRT patients at CHU de Québec - Université Laval center, and therefore this study has no pre-determined recruitment period duration or limited number of participants, and may remain open as long as necessary to fulfill this aim.
The study will continue until all participants have completed a minimum follow-up of 5 years. Interim analyses will be conducted annually.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized PRRT (P-PRRT) | Experimental | Drug: 177Lu-Octreotate177Lu-Octreotate (LuTate) P-PRRT will be administered as follows: * Renal absorbed radiation dose will be prescribed for the 4-cycle induction course (23 Gy) and for each subsequent cycle (6 Gy), with a reduction in cases of impaired renal or bone marrow function, or significant toxicity from prior cycles. * The personalized activity to be administered at each cycle will be derived from renal dose per unit of injected activity that is predicted by patient characteristics or renal dose delivered during prior cycle(s). * Participants responding to the induction course of P-PRRT will be eligible to receive additional consolidation and/or maintenance cycles. * Participants with prior PRRT exposure outside the trial may receive less induction cycles, or only consolidation/maintenance cycle(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient suffering from a progressive and/or symptomatic NET (any site);
- Patient ineligible to, or refusing a potentially curative treatment such as surgical resection;
- Patient who did not respond, is intolerant or refuses other indicated and available palliative treatments;
- Demonstration of overexpression of somatostatin receptor by tumor lesions by scintigraphic imaging (Octreoscan or 68Ga positron emission tomography.
Key exclusion criteria (4 listed)
- Pregnancy;
- Breastfeeding;.
- Very limited survival prognosis (i.e. less than a few weeks, because of the NET disease or any other condition) or Eastern Cooperative Oncology Group (ECOG) 4 performance status;
- Inability to obtain informed consent of the participant.
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-OctreotateAlso: LuTate, 177Lu-[DOTA0,Tyr3]octreotate, 177Lu-DOTATATE* The induction course will consist in 4 cycles at 8-10 weeks intervals. * Concomitant amino acids will be administered for renal protection. * Intra-arterial LuTate administration will be allowed in suitable cases. * Dosimetry will be based on quantitative SPECT/CT imaging. * In patients with hormonal symptoms, somatostatine analogues can be given between P-PRRT cycles. | Drug | Personalized PRRT (P-PRRT) |
Primary outcome
Objective response rate (ORR)
Time frame: 3 months after induction course
Primary efficacy endpoint is the objective response rate on contrast-enhanced CT (or MRI) by RECIST criteria (and secondarily by South Western Oncology Group (SWOG) criteria) at 3 months after the 4th induction cycle of P-PRRT, in comparison to pre-treatment scan (within 3 months before commencing P-PRRT).
6 secondary outcomes
Progression-free survival (PFS)
Time frame: Time from first cycle to date of disease progression or death, reported up to 5 years after accrual closure
Overall survival (OS)
Time frame: Time from first cycle to date of death, reported up to 5 years after accrual closure
Symptomatic response rate
Time frame: 3 months after induction course
Quality of life response
Time frame: 3 months after induction course
Biochemical response
Time frame: 3 months after induction course
Safety determined by type, frequency and severity of adverse events per CTCAE version 4.03 and type, frequency and severity of laboratory toxicities per CTCAE version 4.03
Time frame: From the first treatment cycle administration until 5 years after accrual closure or death, whichever came first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 30506283Del Prete M, Buteau FA, Arsenault F, Saighi N, Bouchard LO, Beaulieu A, Beauregard JM. Personalized 177Lu-octreotate peptide receptor radionuclide therapy of neuroendocrine tumours: initial results from the P-PRRT trial. Eur J Nucl Med Mol Imaging. 2019 Mar;46(3):728-742. doi: 10.1007/s00259-018-4209-7. Epub 2018 Nov 30.
- Individual participant dataSharing planned: No
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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.
Jean-Mathieu Beauregard, MD,MSc,FRCPC principal investigator
CHU de Québec - Université Laval
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-Octreotate in people with Neuroendocrine Tumors and Carcinoid Tumor, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2024. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Objective response rate (ORR) (time frame: 3 months after induction course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02754297, which also lists 1 linked publication.
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 21 Aug 2024.