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Peptide Receptor Radionuclide Therapy
PRRT for Neuroendocrine Tumors (COMPETE Trial)
Phase 3
Waitlist Available
Research Sponsored by ITM Solucin GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Progressive disease based on RECIST 1.1. criteria as evidenced by two morphological imaging examinations made with the same imaging method (either CT or MRI)
Somatostatin receptor positive (SSTR+) disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 months for a period of at least 30 months
Awards & highlights
COMPETE Trial Summary
This trial will compare the effectiveness of two different treatments for inoperable neuroendocrine tumors of the digestive system.
Who is the study for?
This trial is for adults with certain types of neuroendocrine tumors in the digestive system or pancreas that can't be removed by surgery. Participants must have a confirmed diagnosis, measurable disease, positive somatostatin receptor status, and evidence of disease progression. They cannot have had certain prior treatments like mTor inhibitors or PRRT, nor can they be pregnant or unable to consent.Check my eligibility
What is being tested?
The study compares two treatments: Peptide Receptor Radionuclide Therapy (PRRT) using a radioactive drug called 177Lu-Edotreotide versus Everolimus, a targeted molecular therapy. The goal is to see which treatment is more effective and safer for patients with advanced neuroendocrine tumors.See study design
What are the potential side effects?
Possible side effects include reactions to the radioactive drug such as nausea and fatigue; kidney damage; blood cell count changes leading to increased infection risk; liver problems; allergic reactions if sensitive to the medication's components.
COMPETE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has grown despite treatment, confirmed by two scans.
Select...
My condition is positive for somatostatin receptors.
Select...
My cancer is a specific type from the gut or pancreas, confirmed by lab tests.
COMPETE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3 months for a period of at least 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months for a period of at least 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
progression-free survival (PFS)
Secondary outcome measures
overall survival (OS)
COMPETE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 177Lu-edotreotide PRRTExperimental Treatment2 Interventions
177Lu-edotreotide (177Lu-DOTATOC)
A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each.
Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months)
Group II: EverolimusActive Control1 Intervention
Everolimus (Afinitor ®)
Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)
Find a Location
Who is running the clinical trial?
ITM Solucin GmbHLead Sponsor
1 Previous Clinical Trials
202 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
202 Patients Enrolled for Neuroendocrine Tumors
ABX CROOTHER
4 Previous Clinical Trials
1,234 Total Patients Enrolled
PSI CROIndustry Sponsor
6 Previous Clinical Trials
1,949 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has grown despite treatment, confirmed by two scans.I have kidney, liver, heart, or blood issues that could affect my safety during the study.My condition is positive for somatostatin receptors.I am allergic to certain cancer treatment drugs or their ingredients.My doctor believes surgery could potentially cure my condition.My cancer is a specific type from the gut or pancreas, confirmed by lab tests.I have been treated with mTor inhibitors before.I am allergic to edotreotide or everolimus.I have not had radiation to my neuroendocrine tumor or radioembolization therapy in the last 3 months.I have previously undergone peptide receptor radionuclide therapy.I have a serious illness that is not cancer.I plan to use alternative therapies during the study.
Research Study Groups:
This trial has the following groups:- Group 1: 177Lu-edotreotide PRRT
- Group 2: Everolimus
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has 177Lu-edotreotide PRRT undergone FDA approval process?
"There is both pre-existing clinical data to support the efficacy of 177Lu-edotreotide PRRT and multiple rounds of safety testing, so it received a score of 3."
Answered by AI
Are there any more positions available for willing individuals in this experiment?
"At the moment, this trial is not recruiting patients. However, it is worth checking back in the future as the study was most recently updated on 6/7/2022. There are also other trials that might be of interest. For example, there are presently 168 clinical trials actively looking for participants with neuroendocrine tumors and 129 studies for 177Lu-edotreotide PRRT admitting participants."
Answered by AI
Is 177Lu-edotreotide PRRT a new form of treatment?
"The first recorded study of 177Lu-edotreotide PRRT took place in 2008 at Sheba Medical Center. Since then, there have been a total of 411 completed trials. There are 129 trials currently recruiting patients, with a significant concentration in the Boston area of Massachusetts."
Answered by AI
Why is 177Lu-edotreotide PRRT commonly prescribed?
"177Lu-edotreotide can be used as part of PRRT to treat patients with kidney transplants, waldenstrom macroglobulinemia, and lung cancer who have rejected other forms of treatment."
Answered by AI
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