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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

Must not have

Clinically relevant renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments

Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 3 months for a period of at least 30 months

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has grown despite treatment, confirmed by two scans.

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My condition is positive for somatostatin receptors.

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My cancer is a specific type from the gut or pancreas, confirmed by lab tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have kidney, liver, heart, or blood issues that could affect my safety during the study.

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I am allergic to certain cancer treatment drugs or their ingredients.

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My doctor believes surgery could potentially cure my condition.

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I have been treated with mTor inhibitors before.

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I am allergic to edotreotide or everolimus.

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I have previously undergone peptide receptor radionuclide therapy.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months for a period of at least 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

progression-free survival (PFS)

Secondary study objectives

overall survival (OS)

Awards & Highlights

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.

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)

0 / 9Eligibility criteria met