AzTrials
AzTrials

Neuroendocrine TumorsPhase 2NCT04915144

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

A Phase 2 study testing 177Lu-DOTATOC in people with Neuroendocrine Tumors and Carcinoid Tumor, run by British Columbia Cancer Agency at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
177Lu-DOTATOC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
15 Jan 2023to 31 Dec 2031
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 26Show fewer
  • 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
  • Liver
  • Total bilirubin ≤ 3 x upper limit of normal (ULN)
  • ALT ≤ 3 x ULN or ≤ 5 x ULN if liver metastasis
  • Alkaline phosphatase ≤ 3 x ULN or ≤ 5 x ULN if liver metastasis
  • Subject's ability to comply with scheduled visits, treatment plans, laboratory tests, imaging tests, and other procedures required as detailed in the protocol.

Who cannot join

  • Women and men of childbearing potential Procreation
  • Women: pregnancy test done before enrollment before each treatment cycle. And subject must use adequate contraception for the duration of therapy, be surgically sterile, or post-menopausal.
  • Men: must be surgically sterile or use adequate contraception for the duration of the therapy.
  • Patient with another non-cutaneous (excluding melanoma) active cancer requiring therapeutic intervention.
  • Curative medical or surgical treatment, local liver embolization, or debulking are appropriate options.
  • Life expectancy is less than 12 weeks.
Show all 12Show fewer
  • Radiotherapy to target lesions ≤ 12 weeks ago or to more than 25% of bone marrow.
  • PRRT at any time prior to randomization in this study.
  • Systemic therapy (chemotherapy) within 4 weeks of PRRT and other locoregional therapies (radioisotope, embolization) within 12 weeks prior to enrollment. Ongoing use of somatostatin analogs for control of symptoms is allowed.
  • Known brain metastases (unless treated and stable for more than 3 months).
  • Co-morbidities that could, in the opinion of the PI, interfere with safe delivery of PRRT (like urinary incontinence, psychiatric illness), uncontrolled congestive heart failure (NYHA II, III, IV)
  • Breastfeeding (if patients elect to discontinue breast feeding, they can participate in the trial).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • BC Cancer

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Prospective Randomized Study of the Efficacy and Safety of 177Lu-DOTATOC With Either Standard or Personalized Dosing for the Treatment of Patients With Somatostatin Receptor Positive NETs

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).

Read the detailed description

Overall, 200 subjects will be randomized (1:1 randomization ratio) to receive standard injected activities of 177Lu-DOTATOC PRRT or personalized injection of 177Lu-DOTATOC PRRT. Randomization will be stratified for grade and primary location.

Screening Phase: Subjects will be screened against the inclusion and exclusion criteria. Screening by SSR imaging will be completed to determine expression of SSR and feasibility of treatment by PRRT. Once eligibility has been confirmed they will be randomized. Subjects will undergo a physical exam, complete a medical history questionnaire, quality of life questionnaires, blood work, and a diagnostic CT.

Treatment Phase: During the treatment phase, subjects will undergo 4 cycles of treatment. Each treatment cycle will be followed by 2 dosimetry SPECT/CT scans on day 1 (18 - 32 hours after treatment administration) and day 2 (64 - 80h after treatment administration) After cycle 3 quality of life questionnaires will be completed again.

Follow up Phase: At the end of treatment or after discontinuation of any cause, subjects will be followed for 5 years to continue data collection for the other objectives. Objective tumour response will be assessed every 6 months by diagnostic CT according to the RECIST 1.1 criteria.

Being tested
177Lu-DOTATOC
Medical subject headings
Neuroendocrine Tumors, Carcinoid Tumor, Gastro-enteropancreatic neuroendocrine tumor, Vipoma, Insulinoma, Gastrinoma

What participants receive

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

  • 177Lu-DOTATOCDrug

    Subjects will receive 177Lu-DOTATOC PRRT treatment over 4 cycles, each cycle occurs every 8 weeks.

Study groups in NCT04915144
Study groupRoleWhat they receive
Standard PRRTActive comparatorFor standard PRRT 177Lu-DOTATOC therapy, the administered activity will be 7.4 GBq ± 10% as an intravenous infusion over a time of 10 to 30 minutes.
Receives: Drug: 177Lu-DOTATOC
Personalized PRRTExperimentalFor 177Lu-DOTATOC therapy, for the first cycle the administered activity will be 7.4 GBq ± 10% as an intravenous infusion over a time of 10 to 30 minutes.Subsequent cycles will be adjusted based on dosimetry calculations.
Receives: Drug: 177Lu-DOTATOC

What is being measured

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

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

    Frequency of AEs, will be compared between the two treatment arms.

    Measured: 8 months

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

    PFS will be determined by RECIST1.1 criteria on serial CT, and analysed independently. The 12-month PFS will be evaluated by univariate analysis but different criteria for determination of PFS will be compared.

    Measured: 12 months

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

    PFS will be determined by biochemical criteria (ITMO) on serial CT, and analysed independently. The 12-month PFS will be evaluated by univariate analysis but different criteria for determination of PFS will be compared.

    Measured: 12 months

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

    PFS will be determined by Choi criteria on serial CT, and analysed independently. The 12-month PFS will be evaluated by univariate analysis but different criteria for determination of PFS will be compared.

    Measured: 12 months

Secondary outcomes (9)

  1. Determine response rate of both treatment arms with RECIST1.1 criteria

    Response rate as determined by structural criteria RECIST1.1

    Measured: 4 months

  2. Determine response rate of both treatment arms with Choi criteria

    Response rate as determined by structural criteria Choi.

    Measured: 4 months

  3. Determine response rate of both treatment arms with ITMO criteria

    Response rate as determined by structural criteria biochemical markers (ITMO criteria) (chromogranin A, 24h urinary HIAA).

    Measured: 4 months

  4. Quality of life (QoL) questionnaire scores (EORTC QLQ30) will be compared between the two treatment arms

    For QoL questionnaire scores (EORTC QLQ30) before, during, and after treatment

    Measured: 8 months

  5. Quality of life (QoL) questionnaire scores (EORTC GINET21) will be compared between the two treatment arms

    For QoL questionnaire scores (EORTC GINET21) before, during, and after treatment

    Measured: 8 months

  6. Quality of life (QoL) questionnaire scores (EQ-5D) will be compared between the two treatment arms

    For QoL questionnaire scores (EQ-5D) before, during, and after treatment

    Measured: 8 months

  7. Correlation of QoL scores (EORTC QLQ30) to ctDNA

    To assess correlation of QoL scores (EORTC QLQ30) to ctDNA allele frequency change from pre-treatment to on-treatment, using spearman correlation

    Measured: 8 months

  8. Correlation of QoL scores (EORTC GINET21) to ctDNA

    To assess correlation of QoL scores (EORTC GINET21) to ctDNA allele frequency change from pre-treatment to on-treatment, using spearman correlation

    Measured: 8 months

  9. Correlation of QoL scores (EQ-5D) to ctDNA

    To assess correlation of QoL scores (EQ-5D) to ctDNA allele frequency change from pre-treatment to on-treatment, using spearman correlation

    Measured: 8 months

Timeline

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

  1. First posted7 Jun 2021
  2. Study start15 Jan 2023 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Why it stopped: Investigator decision

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
This is a prospective randomized phase II study two-arm study of efficacy and safety of 177Lu-DOTATOC for treatment of patients with NETs who are referred to BC Cancer - Vancouver for treatment of progressive tumours.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04915144
Sponsor's protocol ID
H20-03401
Status last verified
Feb 2023
First submitted
28 Apr 2021
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 177Lu-DOTATOC in people with Neuroendocrine Tumors and Carcinoid Tumor, run by British Columbia Cancer Agency 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 26 inclusion and 12 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: withdrawn, as of the sponsor's last update on 21 Feb 2023. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Determine whether personalized 177Lu-DOTATOC PRRT reduces adverse events (AE). (time frame: 8 months). The study lists 4 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 NCT04915144.

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 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in