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Trial record 11 of 2843 for:    Neuroendocrine Neoplasm | Neuroendocrine Tumors

Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02743741
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : October 23, 2019
Ozmosis Research Inc.
Cancer Care Ontario
Canadian Molecular Imaging Probe Consortium
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE April 13, 2016
First Posted Date  ICMJE April 19, 2016
Last Update Posted Date October 23, 2019
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
The proportion of patients progression-free using RECIST 1.1 criteria [ Time Frame: Up to 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02743741 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
  • The overall response rate as determined by structural imaging using RECIST criteria. [ Time Frame: Up to 5 years ]
  • The biochemical response rate (as defined by biochemical responses: serum chromogranin A and 24 hr urinary 5HIAA). [ Time Frame: Up to 5 years ]
  • The acute and late adverse effects of Lu-DOTATATE (177Lu) using CTCAE Version 4.03 [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: Up to 5 years ]
  • The Quality of Life (QoL) in patients treated with Lu-DOTATATE (177Lu) [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors
Official Title  ICMJE A Prospective Single-Arm, Multi-Centre, Study of the Efficacy and Safety of Lutetium-177 Octreotate (Lu-DOTATATE) Treatment With Individualized Dosimetry in Patients With 68Ga-DOTATATE Identified Somatostatin Receptor Positive Neuroendocrine Tumors
Brief Summary This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE Drug: Lutetium-177 Octreotate
Other Names:
  • [Lu-177]-DOTATATE
Study Arms  ICMJE Experimental: Lutetium-177 Octreotate
Lutetium-177 Octreotate 200 mCi (7.4 GBq) by IV for 18-30 weeks
Intervention: Drug: Lutetium-177 Octreotate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2016)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Please note that only Ontario residents will be eligible for participation in this trial.

Inclusion Criteria:

  1. Biopsy-proven neuroendocrine tumor
  2. ECOG performance status ≤ 2
  3. Ki-67 index ≤ 30%
  4. Evidence of progressive disease demonstrated by imaging within six months prior to study enrollment as defined by RECIST v1.1.

    • Tumor board discussion of cases to confirm suitability for participation in the clinical trial is required. Review should include but not limited to imaging review, pathology (including Ki 67) and treatment options.
    • Patients with objective evidence (imaging, or biochemical) that is insufficient to be classified by RECIST 1.1 criteria can be eligible if after provincial multidisciplinary tumor board discussion a consensus for progression eligibility is reached.
    • The tumor board would consider exemptions if the magnitude of change is adequate by other definitions (e.g. using structural and contrast patterns and biochemical changes).
    • Where clinically indicated, formal consultation on pathology, diagnostic imaging to facilitate criteria assessment (including 68Ga PET performed as part of the diagnostic procedure) is strongly recommended.
  5. Adequate lab parameters within 2 weeks prior to enrollment:

    • Serum creatinine ≤ 150 μmol/L
    • Calculated CrCl or measured GFR ≥ 30 mL/min (measured GFR may be done within 4 weeks prior to enrollment)
    • Haemoglobin ≥ 90 g/L
    • WBC ≥ 2 x 109/L
    • Platelets ≥ 100 x 109/L
  6. Adequate liver function tests within 2 weeks prior to enrollment:

    • total bilirubin ≤ 5 x ULN
    • ALT ≤ 5 x ULN
    • AST ≤ 5 x ULN
    • alkaline phosphatase ≤ 5 x ULN
  7. Signed informed consent
  8. Patients with extensive bone metastases (e.g. >25% of bone marrow involvement are eligible but requires careful monitoring of hematological reserve
  9. Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  10. Age ≥ 18 years.

Exclusion Criteria:

  1. Life expectancy <12 weeks
  2. An option for curative surgical or medical therapy or local liver embolization is feasible
  3. Candidate for curative and/or debulking surgical resections
  4. Systemic, biologic, other radioisotope, embolization therapies within ≤4 weeks prior to the first dose of 177Lu.
  5. Prior radiotherapy to target lesion(s) within ≤12 weeks prior to study enrollment [radiotherapy to non-target lesions permitted].
  6. Prior therapy with any systemic radionuclide therapy.
  7. Radiotherapy to more than 25% of the bone marrow.
  8. Known brain metastases (unless metastases have been treated and are stable for ≥ 6 months).
  9. Uncontrolled diabetes mellitus
  10. Co-morbidities that may interfere with delivery of 177Lu (e.g. urinary incontinence).
  11. Second cancer(s) with clinical or biochemical progression within the last 3 years.
  12. Pregnancy or breast feeding. Female subjects must be surgically sterile or postmenopausal, or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum) prior to enrolment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate
  13. Other condition, illness, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation, 68Ga or 177Lu administration, or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rebecca Wong, M.D. 416-946-2126
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02743741
Other Study ID Numbers  ICMJE OZM-067
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE
  • Ozmosis Research Inc.
  • Cancer Care Ontario
  • Canadian Molecular Imaging Probe Consortium
Investigators  ICMJE Not Provided
PRS Account University Health Network, Toronto
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP