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AzTrials

Neuroendocrine CarcinomaPhase 2NCT02236910

An Open Label Registry Study of Lutetium-177 (DOTA0, TYR3) Octreotate (Lu-DOTA-TATE) Treatment in Patients With Somatostatin Receptor Positive Tumours

A Phase 2 study testing Lu-DOTA-TATE in people with Neuroendocrine Carcinoma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Lu-DOTA-TATE (Lutetium-177 octreotate) is a radiopharmaceutical that has been reported as being effective in controlling symptoms and increase quality of life; induce stable disease and extend progression free survival; induce a (good) partial remission and induce a complete remission in patients with a somatostatin… Read more about this study

Who is it for?
Ages 14 to 90 years
Conditions the study is for
Neuroendocrine Carcinoma
What is being tested?
Lu-DOTA-TATE
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteCanada
Study dates
Jul 2014to Dec 2027
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 14 to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Group A: Primary therapy subjects will be included in the study if they meet all of the following general criteria:
  • Male or female ≥ 14 - 90 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
  • Presence of somatostatin receptor positive tumour(s) (either histologically or Octreoscan image proven), with at least 1 tumour site reliably evaluable by CT or MRI of at least 1.5 cm (smallest dimension) with respect to RECIST criteria (the target lesion).
  • Presence of somatostatin receptors on (at least) the target lesion demonstrated by uptake of OctreoScan® at least equal to liver uptake within 12 weeks of enrollment.
  • Life expectancy greater than 26 weeks from enrollment.
  • Serum creatinine ≤ 130 μmol/L, and a measured glomerular filtration rate (GFR) using plasma clearance of ≥50 mL/min measured within 2 weeks of enrollment.
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  • Haemoglobin concentration ≥ 90 g/L; white blood cell count (WBC) ≥ 3 x 109/L; platelets ≥ 100 x 109/L measured within 2 weeks of enrollment.
  • Liver function tests (serum albumin, total bilirubin, alanine amniotransferase (ALT),aspartate aminotransferase (AST) and alkaline phosphatase) ≤ 3 X the limit of normal.
  • Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrollment.
  • Provide written informed consent prior to enrollment.
  • Ki 67 < 20%, unless patients has been treated with chemotherapy and lesions are stable (Ki 67 < 30%)
  • Group B: Secondary therapy subjects will be included in the study if they meet all of the following general criteria:
  • Male or female ≥ 14 - 90 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
  • Have received Lu-DOTA-TATE treatment at the London Health Sciences Centre under the Special Access Programed or other radionuclide therapy for neuroendocrine tumor.
  • Provide written informed consent prior to enrollment.

Who cannot join

  • Group A: Primary therapy subjects will be excluded from the study if they meet any of the following criteria:
  • Potential for surgery with curative intent. Local surgery for symptomatic relief permitted as long as target lesion unaffected.
  • Surgery, radiation therapy, radioisotope therapy, change in Sandostatin LAR therapy dosage, cytotoxic chemotherapy, embolization or other investigative therapy [interferons, mammalian target of rapamycin (mTOR) inhibitors] within 12 weeks of enrollment. Localized external beam irradiation permitted as long as target lesion unaffected.
  • Known brain metastases unless these metastases have been treated or stable (confirmed by CT) for ≥ 6 months prior to enrollment
  • Uncontrolled diabetes mellitus defined as fasting glucose ≥ 3 X the upper limit of normal within 12 weeks of enrollment.
  • Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence, co-existing malignancies).
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  • Pregnancy.
  • Breast feeding.
  • Prior radiation therapy to more than 25% of the bone marrow.
  • Group B: Secondary therapy subjects will be excluded from the study if they meet any of the following criteria:
  • Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence, co-existing malignancies).
  • Pregnancy.
  • Breast feeding.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

Other trials in Canada

About this study

Official title: An Open Label Phase II, Registry Study of Lutetium-177 (DOTA0, TYR3) Octreotate (Lu-DOTA-TATE) Treatment in Patients With Somatostatin Receptor Positive Tumours

Lu-DOTA-TATE (Lutetium-177 octreotate) is a radiopharmaceutical that has been reported as being effective in controlling symptoms and increase quality of life; induce stable disease and extend progression free survival; induce a (good) partial remission and induce a complete remission in patients with a somatostatin receptor positive tumour.

The purpose of this study is to assess the efficacy of Lu-DOTA-TATE by measuring progression free survival and overall survival. This study will also asses the safety of Lu-DOTA-TATE, and the quality of life of the patients treated with Lu-DOTA-TATE.

Read the detailed description

Neuroendocrine (NET) tumours have secretory and metabolic pathways not typically found in other cancers that can be utilized for molecular imaging and therapeutic targeting. The most important is somatostatin. Somatostatin receptors are useful tools in the diagnosis and treatment of NET tumours because the somatostatin analogue octreotate can be radiolabeled with lutetium-177 for imaging and therapy.

In selected populations of patients, radioisotope therapy in expert hands has been shown to be a safe and effective palliative therapy with stable disease, progression free survival benefit, symptom control and improvements in quality of life. Lutetium-177 (DOTA0, Tyr3) octreotate has been used in a significant number of clinical studies shown to be safe and effective as a therapeutic agent in patients with NET tumours. The investigators intend to further confirm these benefits with lutetium-177 octreotate, which could form the basis for a national registry study leading to registration of this therapeutic intervention.

Being tested
Lu-DOTA-TATE
Keywords
somatostatin receptor positive tumour
Medical subject headings
Carcinoma, Neuroendocrine

What participants receive

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

  • Lu-DOTA-TATEOther

    Also called Lutetium-177 Octreotate, radiopharmaceutical

Study groups in NCT02236910
Study groupRoleWhat they receive
Primary Therapy with Lu-DOTA-TATEExperimentalLu-DOTA-TATE (Lutetium-177 Octreotate) will be administered by intravenous infusion to participants who have not been previously treated with Lu-DOTA-TATE
Receives: Other: Lu-DOTA-TATE
Secondary Therapy with Lu-DOTA-TATEExperimentalPatients who have received previous treatment with Lu-DOTA-TATE (Lutetium-177 Octreotate) under the special access program are eligible to be treated in this study. Patients will receive Lu-DOTA-TATE by intravenous infusion.
Receives: Other: Lu-DOTA-TATE

What is being measured

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

  1. Tumour response measured by RECIST criteria

    Target lesions will be assigned after treatment 1 base done either the Lu-177 scan, or the CT/MRI scan within 2 weeks prior to treatment 1. Tumour response will be measured using response evaluation criteria in solid tumours (RECIST).

    Measured: 7 years (end of study)

Secondary outcomes (2)

  1. Progression Free Survival

    Progression free survival will be measured from the date of enrollment to the date the target lesion progresses as per RECIST criteria, or death sue to any cause.

    Measured: 7 years (end of study)

  2. Quality of Life Response Changes

    Quality of life changes due to treatment with Lu-DOTA-TATE, measured using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire(QLQ) EORTC QLQ-C30.

    Measured: 7 years (end of study)

Timeline

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

  1. First posted11 Sep 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02236910
Sponsor's protocol ID
TX-LUT-001-London
Other IDs
Lu-DOTA-TATE
Status last verified
Oct 2023
First submitted
9 Sep 2014
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No

Publications

  • Swiha MM, Sutherland DEK, Sistani G, Khatami A, Abazid RM, Mujoomdar A, Wiseman DP, Romsa JG, Reid RH, Laidley DT. Survival predictors of 177Lu-Dotatate peptide receptor radionuclide therapy (PRRT) in patients with progressive well-differentiated neuroendocrine tumors (NETS). J Cancer Res Clin Oncol. 2022 Jan;148(1):225-236. doi: 10.1007/s00432-021-03672-w. Epub 2021 Jun 10.

    PubMed 34110489

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lu-DOTA-TATE in people with Neuroendocrine Carcinoma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 15 inclusion and 13 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 5 Oct 2026. 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?

Tumour response measured by RECIST criteria (time frame: 7 years (end of study)). 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 NCT02236910, 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 5 Oct 2026.

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