- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02743741
Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors
July 24, 2023 updated by: University Health Network, Toronto
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
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
195
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada
- Juravinski Cancer Centre
-
London, Ontario, Canada
- London Health Sciences Centre
-
Toronto, Ontario, Canada
- Princess Margaret Cancer Centre
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Toronto, Ontario, Canada
- Sunnybrook Odette Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Please note that only Ontario residents will be eligible for participation in this trial.
Inclusion Criteria:
- Biopsy-proven neuroendocrine tumor
- ECOG performance status ≤ 2
- Ki-67 index ≤ 30%
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.
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
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
- Signed informed consent
- Patients with extensive bone metastases (e.g. >25% of bone marrow involvement are eligible but requires careful monitoring of hematological reserve
- Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Age ≥ 18 years.
Exclusion Criteria:
- Life expectancy <12 weeks
- An option for curative surgical or medical therapy or local liver embolization is feasible
- Candidate for curative and/or debulking surgical resections
- Systemic, biologic, other radioisotope, embolization therapies within ≤4 weeks prior to the first dose of 177Lu.
- Prior radiotherapy to target lesion(s) within ≤12 weeks prior to study enrollment [radiotherapy to non-target lesions permitted].
- Prior therapy with any systemic radionuclide therapy.
- Radiotherapy to more than 25% of the bone marrow.
- Known brain metastases (unless metastases have been treated and are stable for ≥ 6 months).
- Uncontrolled diabetes mellitus
- Co-morbidities that may interfere with delivery of 177Lu (e.g. urinary incontinence).
- Second cancer(s) with clinical or biochemical progression within the last 3 years.
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lutetium-177 Octreotate
Lutetium-177 Octreotate 200 mCi (7.4 GBq) by IV for 18-30 weeks
|
Radiopharmaceutical
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of patients progression-free using RECIST 1.1 criteria
Time Frame: Up to 12 months
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: Up to 5 years
|
Up to 5 years
|
The overall response rate as determined by structural imaging using RECIST criteria.
Time Frame: Up to 5 years
|
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
|
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
|
Up to 5 years
|
The Quality of Life (QoL) in patients treated with Lu-DOTATATE (177Lu)
Time Frame: Up to 5 years
|
Up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2016
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
April 13, 2016
First Submitted That Met QC Criteria
April 14, 2016
First Posted (Estimated)
April 19, 2016
Study Record Updates
Last Update Posted (Actual)
July 25, 2023
Last Update Submitted That Met QC Criteria
July 24, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OZM-067
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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