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Peptide Receptor Radionuclide Therapy

PRRT for Neuroendocrine Tumors (COMPOSE Trial)

Phase 3
Recruiting
Research Sponsored by ITM Solucin GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) with measurable site of disease per RECIST v1.1 using contrast computed tomography (CT) / magnetic resonance imaging (MRI)
Patients aged ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after disease progression
Awards & highlights

COMPOSE Trial Summary

This trial will compare the effects of a new cancer treatment to the best existing cancer treatment.

Who is the study for?
This trial is for adults with aggressive, well-differentiated GEP-NETs that can't be surgically removed and have shown up on scans. Participants must have tumors with somatostatin receptors but cannot join if they're pregnant, breastfeeding, hypersensitive to the drugs being tested, recently had major surgery or other cancer treatments, or have serious health issues affecting their organs.Check my eligibility
What is being tested?
The COMPOSE study is testing whether a treatment called 177Lu-Edotreotide (a type of PRRT) works better as a first or second option compared to standard therapies like CAPTEM, Everolimus, FOLFOX for certain neuroendocrine tumors. Patients will either receive this new therapy or one of the established treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to radiation exposure from PRRT such as nausea and fatigue; kidney damage; blood cell count changes leading to increased infection risk; liver toxicity; and allergic reactions to any component of the treatment.

COMPOSE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My GEP-NETs cancer is confirmed and can't be removed by surgery.
Select...
I am 18 years old or older.
Select...
My condition is positive for somatostatin receptors.

COMPOSE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after disease progression
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after disease progression for reporting.

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
Secondary outcome measures
Overall Survival

COMPOSE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Peptide Receptor Radionuclide Therapy (PRRT) ArmExperimental Treatment2 Interventions
Group II: CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)Active Control3 Interventions

Find a Location

Who is running the clinical trial?

ITM Solucin GmbHLead Sponsor
1 Previous Clinical Trials
309 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
309 Patients Enrolled for Neuroendocrine Tumors

Media Library

177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04919226 — Phase 3
Neuroendocrine Tumors Research Study Groups: Peptide Receptor Radionuclide Therapy (PRRT) Arm, CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)
Neuroendocrine Tumors Clinical Trial 2023: 177Lu-Edotreotide Highlights & Side Effects. Trial Name: NCT04919226 — Phase 3
177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04919226 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there many precedent cases for177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT?

"There are 1099 ongoing clinical trials investigating 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT, with 297 trials in Phase 3. While most of the trials for 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT are located in Guangzhou, Guangdong, there are 38873 locations running studies for 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT."

Answered by AI

Are there any vacancies in this research project for participants?

"That is correct, the listing on clinicaltrials.gov does show that this study is still looking for patients. The trial was originally posted on December 21th 2021 and was updated as recently as September 13th of this year. They are aiming to enroll a total of 202 individuals across 3 different research sites."

Answered by AI

What has 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT been shown to be effective in treating?

"177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT can provide treatment for patients with progressive disease, rectal carcinoma, and lung cancer."

Answered by AI

Is 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT an FDA-sanctioned treatment?

"There is both efficacy and safety data available from Phase 3 trials, which earned 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT a score of 3 on our Power scale."

Answered by AI

How many individuals are included in this research project?

"That is correct. The website clinicaltrials.gov has the latest information on this trial, which was last updated on September 13th, 2022. The study is looking for 202 individuals from 3 different locations."

Answered by AI
~32 spots leftby Sep 2024