WithdrawnPhase 2

177Lu-DOTATOC for the Treatment of Patients With Somatostatin Receptor Positive NETs

Stopped: Investigator decision

Canada0Started 2023-01-15

Plain-language summary

This study is to assess if personalized peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATOC results in fewer adverse events than standard PRRT. Subjects will be randomized to either receive personalized or standard PRRT. Personalized PRRT will be determined based on dosimetry calculations after the first cycle. In addition comparisons, will be made with progression-free survival, serial CT imaging, ctDNA, and quality of life questionnaires. Subjects will be followed for 5 years or until they have progression and are switched to another systemic treatment (not including treatment with somatostatin analogues).

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Able to provide written informed consent * Age greater than or equal to 19 years * Biopsy-proven, well-differentiated grade 1 - 3 NET * Gastroenteropancreatic tumors (e.g. carcinoids, gastrinoma, insulinoma, glucagonoma, VIPoma, etc.), functioning and non-functioning * Sympathoadrenal system tumors (phaeochromocytoma, paraganglioma) * Pulmonary NET, functioning and non-functioning * Easter Cooperative Oncology Group (ECOG) ≤ 2 * Ki67 ≤ 55% * Progressive disease demonstrated by RECIST 1.1 criteria within the 6 months preceding the study. * Patients with other evidence of progressive disease that is not demonstrated on CT (like rising biomarkers) may be included, at the discretion of the Tumour Review Board. * If response to other treatments is considered adequate according to other criteria, the Tumour Review Board may consider excluding the patient from participation in the study. * Tumour Review Board confirmation of suitability to proceed to PRRT treatment and enrollment in this trial. * Positive PET SSR imaging (Krenning score 2 or higher) in previous 6 months (68Ga-DOTATOC, 68Ga-DOTATATE, 18F-AmBF3-TATE). If PET SSR imaging is not available 111In-penetreotide scintigraphy (Octreotide scan) is acceptable. * Adequate laboratory parameters within two weeks of enrollment * Kidneys * Serum creatinine ≤ 150 µmol/L * GFR ≥ 40 ml/min (using plasma clearance values) * Marrow * Hemoglobin ≥ 80 g/L * WBC ≥ 2 x 109/L * Platelets ≥ 75 x 109/L * Liv…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determine whether personalized 177Lu-DOTATOC PRRT reduces adverse events (AE).

Timeframe: 8 months

Compare the 12-month progression-free survival (PFS) of subjects receiving personalized or standard injected activity PRRT with RECIST criteria.

Timeframe: 12 months

Compare the 12-month progression-free survival (PFS) of subjects receiving personalized or standard injected activity PRRT with ITMO criteria.

Timeframe: 12 months

Compare the 12-month progression-free survival (PFS) of subjects receiving personalized or standard injected activity PRRT with Choi criteria.

Timeframe: 12 months

Trial details

NCT IDNCT04915144

SponsorBritish Columbia Cancer Agency

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Neuroendocrine Tumors trials

Plain-language summary

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Determine whether personalized 177Lu-DOTATOC PRRT reduces adverse events (AE).

Timeframe: 8 months

Compare the 12-month progression-free survival (PFS) of subjects receiving personalized or standard injected activity PRRT with RECIST criteria.

Timeframe: 12 months

Compare the 12-month progression-free survival (PFS) of subjects receiving personalized or standard injected activity PRRT with ITMO criteria.

Timeframe: 12 months

Compare the 12-month progression-free survival (PFS) of subjects receiving personalized or standard injected activity PRRT with Choi criteria.

Timeframe: 12 months