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Radioisotope Therapy
Lu-DOTA-TATE for Neuroendocrine Carcinoma
Phase 2
Recruiting
Led By Donald W Morrish, MD, PhD
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Group B (Maintenance Therapy): Have previously received Lu-DOTA-TATE treatment under the SAP
Group A (Primary Therapy): ECOG Performance Scale Score ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 days after each lu-dota-tate treatment
Awards & highlights
Study Summary
This trial is a prospective, single arm, open label study of Lu-DOTA-TATE in patients with well-differentiated, somatostatin receptor positive neuroendocrine tumours.
Who is the study for?
This trial is for individuals with neuroendocrine tumors, aged 14-90, who have a life expectancy of more than 12 weeks and are physically able to perform daily activities (ECOG ≤2). They must have somatostatin receptor positive tumors confirmed by imaging and meet specific blood test criteria. Those previously treated with Lu-DOTA-TATE or having certain medical conditions are excluded.Check my eligibility
What is being tested?
[177]Lu-DOTA-TATE therapy is being tested for its effectiveness in treating neuroendocrine tumors and its impact on patients' quality of life and survival. The study will also evaluate the safety of this treatment which has been used under special access but now requires clinical trial assessment.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, nausea, fatigue, bone marrow suppression leading to low blood cell counts, kidney damage, liver toxicity, hormonal imbalances and potentially others not listed here.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have previously received Lu-DOTA-TATE treatment.
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I can take care of myself and perform daily activities.
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I am between 14 and 90 years old.
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My tumor shows up more brightly than my liver on specific scans.
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My liver is functioning well, and my blood protein levels are normal.
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I have a confirmed diagnosis of a neuroendocrine tumor.
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My kidney function is good, with creatinine levels low and GFR above 50 mL/min.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer is growing or has spread, as shown by imaging tests.
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My kidney function is good, with creatinine ≤ 150 µmol/L and GFR ≥ 50 mL/min.
Select...
My doctor expects me to live more than 12 weeks.
Select...
I am between 14 and 90 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 days after each lu-dota-tate treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 days after each lu-dota-tate treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Body Weight Changes
Lu-177 scan disease evaluation
+1 moreSecondary outcome measures
Change in Quality of Life (EORTC QLQ)
Change in Quality of Life (ESAS-r)
Change in haematology
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: [177]Lu-DOTA-TATE TherapyExperimental Treatment1 Intervention
Nominal, induction stage dose of 150 mCi (5.55 GBq) [177]Lu-DOTA-TATE every 10 - 14 weeks for 4 treatments.
Nominal maintenance stage dose of 75 mCi (2.78 GBq) [177]Lu-DOTA-TATE every 22 - 40 weeks, up to a maximum of 8 treatments.
Find a Location
Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
35,712 Total Patients Enrolled
Donald W Morrish, MD, PhDPrincipal InvestigatorProfessor of Endocrinology and Oncology, University of Alberta, Cross Cancer Institute
1 Previous Clinical Trials
250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously received Lu-DOTA-TATE treatment.My liver is functioning well, and my blood protein levels are normal.My diabetes has been uncontrolled in the last 3 months.I have a serious health or mental condition not managed by treatment.I have a confirmed diagnosis of a neuroendocrine tumor.My kidney function is good, with creatinine levels low and GFR above 50 mL/min.Your hemoglobin, white blood cell count, and platelet levels are within certain healthy ranges.I am a candidate for surgery to remove my cancer.Your liver function tests should be within 3 times the normal limit, and your serum albumin level should be at least 23 g/L.I am receiving my first treatment within the set timeframes.I have had radiation therapy to over 25% of my bone marrow.I can take care of myself and perform daily activities.I am between 14 and 90 years old.You need to have a certain level of red blood cells, white blood cells, and platelets in your blood to participate in the study.I have received Lu-DOTA-TATE therapy before.I had a liver embolization within the last 4 weeks.I haven't changed my long-acting somatostatin analogues in the last 12 weeks.My tumor shows up more brightly than my liver on specific scans.I can take care of myself but might not be able to do heavy physical work.My cancer is growing or has spread, as shown by imaging tests.My kidney function is good, with creatinine ≤ 150 µmol/L and GFR ≥ 50 mL/min.My doctor expects me to live more than 12 weeks.I am between 14 and 90 years old.My brain metastases have been treated and stable for 4 months.Before joining the study, you had a full-body PET/CT scan using a special imaging substance called 18F-FDG within the last 26 weeks.I have received radioisotope therapy within the last 3 months.I have given my written consent to participate.I will have surgery within 12 weeks of joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: [177]Lu-DOTA-TATE Therapy
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you explain the participant requirements for this trial?
"The minimum age for enrollment in this clinical trial is 14 and the maximum age is 90."
Answered by AI
How many people are the researchers hoping to test in this clinical trial?
"That is correct, the clinical trial is still looking for 500 enrollees. The study was posted on 4/29/2014 and updated as recently as 4/12/2021 according to clinicaltrials.gov."
Answered by AI
Is [177]Lu-DOTA-TATE a safe medical treatment for patients?
"There is some clinical data supporting the safety of [177]Lu-DOTA-TATE, but none for efficacy. Our team has rated it a 2 on our scale."
Answered by AI
Which patients fit the screening criteria for this research?
"This specific clinical trial is looking for 500 patients that have carcinoma or neuroendocrine. The ages of the participants must be 14-90. In addition, they must meet the following requirements:"
Answered by AI
Are we still able to sign up for this experiment?
"The trial is still open and recruiting patients, according to the information available on clinicaltrials.gov. The study was first posted on 4/29/2014, with the most recent edit taking place on 4/12/2021."
Answered by AI
Are there similar procedures to [177]Lu-DOTA-TATE that have been trialed before?
"[177]Lu-DOTA-TATE is being trialed in 23 separate studies, one of which is in Phase 3. The global trial locations number 162, with the majority taking place in Cleveland, Ohio."
Answered by AI
What is the primary aim of this clinical trial?
"The purpose of this study, which will be evaluated over the course of several months and years, is to observe changes in tumour response in patients after treatment. Additionally, this trial aims to secondary outcomes like change in liver function and quality of life. To do so, blood samples will be taken at various intervals to monitor for toxicity levels and questionnaires will be administered to gauge quality of life. The safety and tolerability of the medication will also be monitored for any adverse events that may occur during or after treatment."
Answered by AI
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