Study comparing 177Lu-edotreotide versus everolimus in patients with inoperable progressive neuroendocrine tumors of gastroenteric or pancreatic origin

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What is this study about?

This study focuses on patients with neuroendocrine tumors that originate in the digestive system or pancreas (GEP-NET). These are rare tumors that develop from hormone-producing cells in these organs. The study compares two different treatments: a radioactive medication called 177Lu-Edotreotide given through intravenous infusion, and everolimus (also known as Afinitor) taken as tablets by mouth.

The purpose of the study is to determine if treatment with 177Lu-Edotreotide is more effective at slowing down tumor growth compared to everolimus in patients whose tumors cannot be removed by surgery and continue to grow. During the study, patients will receive either 177Lu-Edotreotide through an intravenous infusion along with a protective amino acid solution, or they will take everolimus tablets daily.

The treatment with 177Lu-Edotreotide, known as Peptide Receptor Radionuclide Therapy (PRRT), involves giving a radioactive substance that specifically targets tumor cells. Patients receiving this treatment will also get an Arginine-Lysine solution through an intravenous line to protect their kidneys. Those in the everolimus group will take tablets that work by blocking signals that cancer cells use to grow.

1 Initial treatment assignment

You will be randomly assigned to one of two treatment groups

The assignment determines whether you will receive 177Lu-Edotreotide through intravenous infusion or Everolimus tablets

2 Treatment pathway A – 177Lu-Edotreotide

If assigned to this group, you will receive 177Lu-Edotreotide through an intravenous infusion

Before each 177Lu-Edotreotide treatment, you will receive an Arginine-Lysine solution through intravenous infusion for kidney protection

3 Treatment pathway B – Everolimus

If assigned to this group, you will take Everolimus tablets orally

The tablets come in two possible strengths: 5 mg or 10 mg

You will need to take the tablets as prescribed by your doctor

4 Regular monitoring

Your condition will be regularly assessed through medical imaging to track disease progression

Regular health checks will include vital signs, heart monitoring (ECG), and laboratory tests

You will complete quality of life questionnaires about your health status

5 Safety monitoring

Your kidney function will be regularly monitored

Any side effects or unusual symptoms will be recorded

Regular assessments of your overall health status will be conducted

6 Study duration

The study continues until March 2029

Your participation duration will depend on how your condition responds to treatment

Treatment will continue until disease progression or if you need to stop for other medical reasons

Who Can Join the Study?

You must provide written informed consent to participate in the study
You must be 18 years or older, both men and women can participate
You must have a confirmed diagnosis of well-differentiated neuroendocrine tumor (a type of slow-growing tumor) that originates from either:
– the digestive tract (gastroenteric) or
– the pancreas
Your disease must be measurable through imaging scans according to specific measurement criteria (RECIST 1.1)
Your tumor must be somatostatin receptor positive (meaning it has specific proteins on its surface that can be targeted by treatment)
You must have progressive disease, which means your condition has worsened over time, as shown by two imaging scans (either CT or MRI) using the same method

Who Cannot Join the Study?

History of any other cancer within the last 3 years (except adequately treated non-melanoma skin cancer or carcinoma in situ)
Previous treatment with PRRT (Peptide Receptor Radionuclide Therapy) or everolimus
Severe heart problems, including heart failure or uncontrolled heart rhythm disorders
Severe kidney problems (creatinine clearance less than 50 mL/min)
Severe liver problems, including cirrhosis or liver failure
Pregnant or breastfeeding women
Uncontrolled diabetes (blood sugar levels that are not well managed)
Active or untreated brain metastases (cancer that has spread to the brain)
Major surgery within 4 weeks before starting the study
Any serious medical condition that could interfere with study participation
Known allergies to study medications or their components
Participation in another clinical trial within 30 days before this study
Unable to follow study procedures or attend scheduled visits
Life expectancy less than 6 months

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Centre Jean Perrin	Clermont Ferrand	France
Medical University Of Vienna	Vienna	Austria
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Zentralklinik Bad Berka GmbH	Bad Berka	Germany
Hopital Beaujon	Clichy	France
Hospital Edouard Herriot	Lyon	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Magdeburg AöR	Magdeburg	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
University Hospital Olomouc	Olomouc	Czechia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Islbvtpb Rsesswqn Dc Chedge Dk Mudfpaeqgji	Montpellier	France
Uqdcqfmsqk Mjblzfr Ccrtbh Hyyokamrqtaiqmvit	Hamburg	Germany
Uzfijijsziawqwftqywxu Elgmo Amj	Essen	Germany
Iuofwiwv Cyesrk Duaywdgsipoiphgdj	L'hospitalet De Llobregat	Spain
Fugniysb nrougrlyi Mpdno a Hpdpsvw	Prague	Czechia
Ihtyhngk Rxzsiqnlc Ppf Lx Sozvnk Dgt Tlffnv Dzsu Akpoxga Iecp Sskkjg	Meldola	Italy
Ahzdkoxbk Uhs	Amsterdam	The Netherlands
Nyezrtvg Ixwyycpa Onhjixjpp Ivr Mlrca Socguesdqiicdvhmazqqyldsbadn Isemamzg Bldavmdi	Cracow	Poland
Uqgaigsgffqfodzwvxkwt Wcmxpwidb Aru	Wuerzburg	Germany
&pmqfivpijbqjxydzyfu Icusefj Cjnxjyqjtff	Warsaw	Poland
Hqfiyepj Vbmu dcnjtifj	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	29.03.2018
Belgium	Not recruiting	29.03.2018
Czechia	Not recruiting	29.03.2018
France	Not recruiting	29.03.2018
Germany	Not recruiting	29.03.2018
Italy	Not recruiting	29.03.2018
Poland	Not recruiting	29.03.2018
Spain	Not recruiting	29.03.2018
The Netherlands	Not recruiting	29.03.2018

Trial locations

Investigated drugs:

177Lu-Edotreotide
This is a radioactive medication used in Peptide Receptor Radionuclide Therapy (PRRT). It targets specific receptors found on neuroendocrine tumors to deliver radiation directly to cancer cells. This treatment is designed for patients with gastrointestinal or pancreatic neuroendocrine tumors that cannot be surgically removed.

Everolimus
This is a targeted therapy medication that works by blocking certain proteins that help cancer cells grow and divide. It is taken as a tablet and is used to treat various types of cancer, including neuroendocrine tumors of the digestive system and pancreas. It belongs to a class of drugs known as mTOR inhibitors.

Neuroendocrine tumors (GEP-NETs) – A group of rare tumors that develop in the cells of the digestive system (gastrointestinal tract) or pancreas. These tumors begin in specialized cells called neuroendocrine cells, which have traits similar to nerve cells and hormone-producing cells. GEP-NETs typically grow slowly over several years and can produce various hormones. The tumors can develop in different parts of the digestive system or pancreas, affecting the normal function of these organs. These tumors can vary in their behavior and characteristics depending on their location and the type of cells involved.

Trial ID:

2023-510444-21-00

Protocol code:

ITM-LET-01

NCT ID:

NCT03049189

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study comparing 177Lu-edotreotide versus everolimus in patients with inoperable progressive neuroendocrine tumors of gastroenteric or pancreatic origin

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?