CLINICAL TRIAL

Y-90 microspheres for Neuroendocrine Tumors

Locally Advanced
Metastatic
Waitlist Available · 18+ · All Sexes · Denver, CO

This study is evaluating whether a combination of two treatments can improve the survival of patients with NETs.

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About the trial for Neuroendocrine Tumors

Eligible Conditions
Neuroendocrine Tumors · Neoplasms · Gastrointestinal Neoplasms · Carcinoid Tumors · Carcinoid Tumor · Digestive System Neoplasms

Treatment Groups

This trial involves 2 different treatments. Y-90 Microspheres is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Y-90 microspheres
DEVICE
Lanreotide
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lanreotide
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Metastatic well-to-moderately differentiated (or low-grade) neuroendocrine carcinoma, including typical carcinoid or pancreatic islet cell carcinoma.
Computerized tomography (CT) scan evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent at the time of study entry. If a CT scan is not possible, then an MRI may be used.
Patients who are currently receiving or have previously received lanreotide or another somatostatin analogue are eligible. Previous treatment with lanreotide or another somatostatin analogue is not required for study entry.
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Adequate hematologic, hepatic and renal function.
Male patients with female partners of childbearing potential and women patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 3 months (90 days) following last dose of study drug(s). Male patients must also refrain from donating sperm during their participation in the study and for 3 months after last dose of study drug(s).
Life expectancy ≥ 3 months.
Willingness and ability to comply with study and follow-up procedures.
Ability to understand the nature of this study and give written informed consent.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, projected 1 year.
Screening: ~3 weeks
Treatment: Varies
Reporting: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, projected 1 year.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, projected 1 year..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Y-90 microspheres will improve 1 primary outcome and 4 secondary outcomes in patients with Neuroendocrine Tumors. Measurement will happen over the course of every cycle (28 days) until disease progression or unacceptable toxicity, projected up to 1 year.

Number of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) as a measure of safety
EVERY CYCLE (28 DAYS) UNTIL DISEASE PROGRESSION OR UNACCEPTABLE TOXICITY, PROJECTED UP TO 1 YEAR
The incidence of AEs and SAEs for all patients who receive at least 1 dose of both study medications will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
EVERY CYCLE (28 DAYS) UNTIL DISEASE PROGRESSION OR UNACCEPTABLE TOXICITY, PROJECTED UP TO 1 YEAR
Overall Survival
AT 12 WEEKS POST-TREATMENT WITH SIR-SPHERES THEN EVERY 8 WEEKS, PROJECTED 1 YEAR.
The time from Day 1 of study drug administration until death from any cause.
AT 12 WEEKS POST-TREATMENT WITH SIR-SPHERES THEN EVERY 8 WEEKS, PROJECTED 1 YEAR.
Overall Response Rate
AT 12 WEEKS POST-TREATMENT WITH SIR-SPHERES THEN EVERY 8 WEEKS, PROJECTED 1 YEAR.
Proportion of patients with confirmed complete or partial response (CR or PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR=disappearance of all target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
AT 12 WEEKS POST-TREATMENT WITH SIR-SPHERES THEN EVERY 8 WEEKS, PROJECTED 1 YEAR.
Disease Control Rate
AT 12 WEEKS POST-TREATMENT WITH SIR-SPHERES THEN EVERY 8 WEEKS, PROJECTED 1 YEAR.
Proportion of patients with CR, PR or stable disease (SD) according to RECIST v1.1.
AT 12 WEEKS POST-TREATMENT WITH SIR-SPHERES THEN EVERY 8 WEEKS, PROJECTED 1 YEAR.
Progression Free Survival
AT 12 WEEKS POST-TREATMENT WITH SIR-SPHERES THEN EVERY 8 WEEKS, PROJECTED 1 YEAR.
The time from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on study.
AT 12 WEEKS POST-TREATMENT WITH SIR-SPHERES THEN EVERY 8 WEEKS, PROJECTED 1 YEAR.

Patient Q & A Section

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

What are the common side effects of y-90 microspheres?

Findings from a recent study provides preliminary evidence supporting the use of Y90 microspheres for the treatment of neuroendocrine tumors of the pancreas and liver, and suggests that a patient's risk of toxicity is predictive of the likelihood of a response to treatment.

Anonymous Patient Answer

How serious can neuroendocrine tumors be?

Based on this data, serious problems may be anticipated in the treatment of patients with neuroendocrine tumors. The risk of aggressive tumor behavior, tumor proliferation or regression when new drug therapies arrive in the therapeutic arsenal, must be considered with caution before treatment and carefully followed during therapy.

Anonymous Patient Answer

What are common treatments for neuroendocrine tumors?

Many neuroendocrine tumors can be treated with surgical removal (surgery for neuroendocrine tumors of the pancreas or for neuroendocrine tumors of the pancreas and liver) or medical therapies depending on the type of tumor and other factors. Surgical treatment includes liver transplantation for hepatic hormone secreting tumors that cause hepatic dysfunction and resection for tumors that affect portal vein flow or lead to portal hypertension. Many other tumors of neuroendocrine origin do not affect the liver and do not produce any demonstrable endocrine dysfunction. Treatment of these tumors depends on the location of the tumors and in some cases, the extent of disease.

Anonymous Patient Answer

What causes neuroendocrine tumors?

Neuroendocrine tumors may develop from an abnormal cell which releases hormones or which has a mutation that causes the cell to release hormones. Rarely, a new hormone, hormone-like substance, or protein may cause neuroendocrine tumors by stimulating receptor-cells to release hormones.

Anonymous Patient Answer

How many people get neuroendocrine tumors a year in the United States?

Approximately 452,600 in the United States will develop a neuroendocrine tumor each year and more than 2,000 of these people will die. The five most common types of neuroendocrine tumor are carcinoid, medullary thyroid, parathyroid, pancreatic, and nonfunctional neuroendocrine tumors.

Anonymous Patient Answer

What is neuroendocrine tumors?

We found that approximately 2% of newly diagnosed patients with solid tumors, including NSCLC, would be candidates for endocrine therapy. However, as is true for all patients with solid tumors, the determination of which treatment to use is complex owing to the heterogeneity of these neoplasms. Clin Cancer Res; 20(16); 4153-9. ©2014 AACR.

Anonymous Patient Answer

What are the signs of neuroendocrine tumors?

Many signs of neuroendocrine tumors involve the skin, including changes in the hair, nails and eye pigmentation (of course, these may be nonspecific). Symptoms, such as headaches, fatigue and malaise, are also signs of neuroendocrine tumors. A large number of symptoms involve the gastrointestinal system. For the most part, however, the signs of neuroendocrine tumors are nonspecific.

Anonymous Patient Answer

Can neuroendocrine tumors be cured?

There is only moderate resolution of symptoms from patients treated for carcinoid and medullary thyroid cancer. Larger studies are needed to validate existing data. Patients with metastatic disease have a dismal prognosis; consequently, treatment strategies are mainly palliative.

Anonymous Patient Answer

How quickly does neuroendocrine tumors spread?

NE tumor patients at the time of primary diagnosis had a statistically significantly reduced PFS compared to patients with metastatic disease at the time of initiation of treatment with NETS, suggesting that NETs should be treated very cautiously in the metastatic setting.

Anonymous Patient Answer

Have there been other clinical trials involving y-90 microspheres?

There has been only one study comparing y-90 to a standard chemotherapeutic and no trials directly comparing y-90 with another type. Therefore, the evidence for it is not conclusive in terms of its safety, effectiveness, and optimum duration of treatment. The patient-to-patient variation in tumor volume, particularly when the tumor is more or less uniformly radiosurgery injected, should be taken in account in comparing Y-90 and other techniques. More data are indicated, including additional patient selection criteria and methods of randomization.

Anonymous Patient Answer

What does y-90 microspheres usually treat?

Although no studies have been published, in-frame Y-90 microsphere treatments are often used for several indications. There are no clear published data or case series demonstrating that Y-90 therapy has a therapeutic role in patients with cancer. However there is some evidence that patients with thyroid tumors may respond much better to radiotherapy using Y-90, as compared with other treatments. The efficacy is greater with the application of multiple administrations of injections, while the number of visits may seem high in comparison with other radiotherapeutic procedures.

Anonymous Patient Answer

What is the survival rate for neuroendocrine tumors?

There is a need to evaluate whether the differences exist between treatment protocols and survival rates. Furthermore, survival statistics related to neuroendocrine tumors should be collected in prospective multicenter studies.

Anonymous Patient Answer
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