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Neuroendocrine TumorsPhase 2LUTHREENCT03454763

Optimizing the Interval Between Cycles of PRRT with 177lu-dotatate in Sstr2 Positive Tumors

A Phase 2 study testing PRRT every 5 weeks and PRRT every 8-10 weeks 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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Randomized Phase II Trial in sstr2 Positive Tumors to Optimize the Interval Between Cycles of PRRT With 177lu-dotatate 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?
PRRT every 5 weeks and PRRT every 8-10 weeks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
618 participants
Where
1 siteItaly
Study dates
26 May 2016to Jan 2025
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

  • Age \>18 years.
  • Patients must have histologically or cytologically confirmation of neuroendocrine tumors or any other tumor histotype documented as sst2-positive), that may benefit from receptor radionuclide therapy and for which there aren't any other effective treatments. For cerebral sst2-positive tumors, if biopsy is no feasible for technical reason or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest oncological lesion confirming the 68Ga PET-CT dota-peptide SSTr2 positivity..
  • Measurable disease according to RECIST 1.1.criteria also patients without measurable but with evaluable disease disease can be enrolled.
  • Any disease stage is allowed. Patients with documented disease will be admitted to therapeutic phase only if the diagnostic OctreoScan (the tumour uptake will be evaluated with a 3-grade scale, where 1 = liver uptake, 2 \> liver uptake and \< kidney uptake and 3 \> kidney uptake: only tumour uptakes grade 2 and 3 will be considered for therapy) and/or Positron Emission Tomography (PET)/CT 68Ga-peptide images demonstrate a significant uptake in the tumour.
  • Patients with progressive disease in pre-study period (PD within the last 12 months), refractory to conventional standard treatments; clinical progression is allowed
  • Patients with or without concurrent therapy with somatostatin analogs
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  • Life expectancy of greater than 6 months.
  • Eastern Cooperative Oncology Group (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 aminotransferase ( ALT) and Aspartate aminotransferase (AST) \<2.5 X UNL (\< 5 X UNL in presence of liver metastases, creatinine \< 2 mg/dL.
  • If female of childbearing potential highly effective birth control methods, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials", (2014_09_15 section 4.1) are mandatory. Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required (established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), for more than 6 months.
  • Participant is willing and able to give informed consent for participation in the study.

Who cannot join

  • 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 23 Gy and more than 1.8 Gy for the bone marrow or as surrogate of dosimetry (13).
  • Patients which are included in the indication of LUTATHERA®
  • 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)
  • ECOG performance status \>2
  • Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
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  • 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.
  • Assessed bone marrow invasion \> 50% (with Bone Marrow biopsy or instrumental exams i.e. bone scan or CT or MRI)
  • Pregnant or breastfeeding women are excluded from the present study.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

    Meldola, FC, 47014

Other trials in Italy

About this study

Official title: Randomized Phase II Trial in Sstr2 Positive Tumors to Optimize the Interval Between Cycles of PRRT with 177lu-dotatate

Randomized Phase II Trial in sstr2 Positive Tumors to Optimize the Interval Between Cycles of PRRT With 177lu-dotatate

Read the detailed description

The main objective of this randomized phase II comparative study is to evaluate the Progression Free survival (PFS) and the safety as co-primary objective of two different schedule of administrations of 177lu-dotatate: intensive (every 5 weeks) vs no intensive (every 8-10 weeks) The secondary objectives are DCR, the late toxicity, OS and dosimetry. Patients with any tumor histotype documented as sst2-positive in pre-study period will be enrolled in the study.

The study will include a total of 618 planned patients. They will be randomly assigned to receive 5 cycles of PRRT at intervals of 5 or 8-10 weeks between cycles.

Being tested
PRRT every 5 weeks, PRRT every 8-10 weeks
Keywords
sst2-positive tumors, Neuroendocrine Tumors, radiolabelled somatostatin analogues (PRRT)
Medical subject headings
Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRRT every 5 weeksDrug

    PRRT (radiolabelled somatostatin analogues) every 5 weeks for 5 cycles

  • PRRT every 8-10 weeksDrug

    PRRT (radiolabelled somatostatin analogues) every 8-10 weeks for 5 cycles

Study groups in NCT03454763
Study groupRoleWhat they receive
Arm A, IntensiveExperimentalArm A, Intensive every 5 weeks
Receives: Drug: PRRT every 5 weeks
Arm B, Non IntensiveExperimentalArm B, Non Intensive every 8-10 weeks
Receives: Drug: PRRT every 8-10 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    Progression free survival is defined as the time from the randomization date to the date of first observation of documented disease progression or death due to any cause

    Measured: up to 5 years

  2. Incidence of Treatment-Emergent Adverse Events

    The evaluation of Treatment-Emergent Adverse Events, defined as any G3/G4 toxicity from 1st treatment cycle until 30 days after the last treatment cycle will be based on version 4.0 CTC-AE

    Measured: up to 30 days after last treatment cycle

Secondary outcomes (2)

  1. DCR

    Disease Control Rate (DCR) is defined as the percentage of patients who have achieved complete response, partial response and stable disease for at least 12 weeks from therapy start. DCR will be evaluated using the new international criteria proposed by the Version 1.1 Response Evaluation Criteria in Solid Tumors (RECIST)

    Measured: up to 5 years

  2. OS

    Overall Survival (OS) is defined as the time from treatment start to the time of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2018
  2. Study start26 May 2016
  3. Primary completionJan 2025 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

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
Model description
comparative
Masking
None (open label)
Enrolment
618 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03454763
Sponsor's protocol ID
IRST100.26
Acronym
LUTHREE
Status last verified
Sep 2024
First submitted
27 Feb 2018
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Grassi I, Nicolini S, Marini I, Matteucci F, Ranallo N, Di Iorio V, Sarnelli A, Foca F, Monti M, Fabbri L, Fantini L, Rossi A, Paganelli G, Severi S, Sansovini M. Lu-PRRT Used More Intensively on Advanced Gastro-Entero-Pancreatic and Lung Neuroendocrine Neoplasms: Preliminary Results on Toxicity from a Randomized Study. Neuroendocrinology. 2025;115(5):434-445. doi: 10.1159/000542328. Epub 2024 Nov 21.

    PubMed 39571544

  • Di Franco M, Zanoni L, Fortunati E, Fanti S, Ambrosini V. Radionuclide Theranostics in Neuroendocrine Neoplasms: An Update. Curr Oncol Rep. 2024 May;26(5):538-550. doi: 10.1007/s11912-024-01526-5. Epub 2024 Apr 6.

    PubMed 38581469

  • Lechner M, Takahashi Y, Turri-Zanoni M, Liu J, Counsell N, Hermsen M, Kaur RP, Zhao T, Ramanathan M Jr, Schartinger VH, Emanuel O, Helman S, Varghese J, Dudas J, Riechelmann H, Sprung S, Haybaeck J, Howard D, Engel NW, Stewart S, Brooks L, Pickles JC, Jacques TS, Fenton TR, Williams L, Vaz FM, O'Flynn P, Stimpson P, Wang S, Hannan SA, Unadkat S, Hughes J, Dwivedi R, Forde CT, Randhawa P, Gane S, Joseph J, Andrews PJ, Royle G, Franchi A, Maragliano R, Battocchio S, Bewicke-Copley H, Pipinikas C, Webster A, Thirlwell C, Ho D, Teschendorff A, Zhu T, Steele CD, Pillay N, Vanhaesebroeck B, Mohyeldin A, Fernandez-Miranda J, Park KW, Le QT, West RB, Saade R, Manes RP, Omay SB, Vining EM, Judson BL, Yarbrough WG, Sansovini M, Silvia N, Grassi I, Bongiovanni A, Capper D, Schuller U, Thavaraj S, Sandison A, Surda P, Hopkins C, Ferrari M, Mattavelli D, Rampinelli V, Facchetti F, Nicolai P, Bossi P, Henriquez OA, Magliocca K, Solares CA, Wise SK, Llorente JL, Patel ZM, Nayak JV, Hwang PH, Lacy PD, Woods R, O'Neill JP, Jay A, Carnell D, Forster MD, Ishii M, London NR Jr, Bell DM, Gallia GL, Castelnuovo P, Severi S, Lund VJ, Hanna EY. Clinical outcomes, Kadish-INSICA staging and therapeutic targeting of somatostatin receptor 2 in olfactory neuroblastoma. Eur J Cancer. 2022 Feb;162:221-236. doi: 10.1016/j.ejca.2021.09.046. Epub 2021 Dec 31.

    PubMed 34980502

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PRRT every 5 weeks and PRRT every 8-10 weeks 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 9 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: status not confirmed, as of the sponsor's last update on 19 Sep 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 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?

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?

PFS (time frame: up to 5 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?

On the ClinicalTrials.gov record for NCT03454763, which also lists 3 linked publications.

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 19 Sep 2024.

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