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Active, Not Recruiting

NCT Number: NCT02754297

Personalized PRRT of Neuroendocrine Tumors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neuroendocrine Tumors Adenocarcinoma Carcinoid Tumor Carcinoma Carcinoma, Neuroendocrine Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Québec - Université Laval

Québec, Quebec, G1R 2J6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

177Lu-Octreotate

Drug
  • 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.

Other names: LuTate, 177Lu-[DOTA0,Tyr3]octreotate, 177Lu-DOTATATE

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

    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.

  2. Overall survival (OS)

    Time frame: Time from first cycle to date of death, reported up to 5 years after accrual closure

  3. Symptomatic response rate

    Time frame: 3 months after induction course

    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.

  4. Quality of life response

    Time frame: 3 months after induction course

    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.

  5. Biochemical response

    Time frame: 3 months after induction course

    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.

  6. 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

Other outcomes

  1. Tumor radiation dose-response relationship

    Time frame: 3 months after induction course

    Correlation between cumulative absorbed radiation dose to tumor lesions and 3-month objective response rate, as defined above

  2. Tumor radiation dose-survival relationship

    Time frame: At least 5 years after first cycle or until study completion, whichever came first

    Correlation between cumulative absorbed radiation dose to tumor lesions and survival endpoints above (PFS and OS)

  3. Renal radiation dose-chronic toxicity relationship

    Time frame: At least 5 years after first cycle or until study completion, whichever came first

    Correlation between cumulative absorbed radiation dose to kidney and variations in glomerular filtration rate from baseline, reported annually for at least 5 years after first cycle or until study completion.

  4. Bone marrow radiation dose-chronic toxicity relationship

    Time frame: At least 5 years after first cycle or until study completion, whichever came first

    Correlation between cumulative absorbed radiation dose to bone marrow and chronic variations of blood counts from baseline, reported annually for at least 5 years after first cycle or until study completion.

  5. Bone marrow radiation dose-subacute toxicity relationship

    Time frame: Time of nadir blood counts values between 2 and 6 weeks after each cycle

    Correlation between per-cycle absorbed radiation dose to bone marrow and subacute variations (nadir values between 2 and 6 weeks) of blood counts from baseline, for each cycle.

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

Personalized Peptide Receptor Radionuclide Therapy of Neuroendocrine Tumors: A Phase 2 Study

Acronym: P-PRRT

Important dates

Study start
2016
Primary completion
2025
Study completion
2029
First posted
Apr 28, 2016
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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