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Anti-metabolites

CapTem + Radioembolization for Liver Metastases from Neuroendocrine Tumors (CapTemY90 Trial)

Phase 2

Recruiting

Led By MICHAEL C SOULEN, MD

Research Sponsored by Abramson Cancer Center of the University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with confirmed diagnosis of histologic grade 2 neuroendocrine tumor with unresectable liver metastases (primary tumor or other extrahepatic disease may be present)

Patent main portal vein

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

CapTemY90 Trial Summary

This trial is testing a combination of drugs to treat neuroendocrine tumors that have spread to the liver. The drugs are capecitabine, temozolomide, and yttrium-90 radioembolization. The study is to see if this combination is more effective than other treatments and has fewer side effects.

Who is the study for?

This trial is for adults over 18 with grade 2 neuroendocrine tumors and liver metastases that can't be removed by surgery. Participants need measurable liver disease, at least half of their tumor burden in the liver, proper organ function, and no recent treatments. They must not be pregnant or breastfeeding and agree to use contraception.Check my eligibility

What is being tested?

The study tests a combination of Capecitabine and Temozolomide tablets with SIR-Spheres radioembolization to treat liver metastases from neuroendocrine tumors. It's a Phase 2 trial aiming to confirm the effectiveness of this integrated chemoradiation approach.See study design

What are the potential side effects?

Potential side effects include those related to chemotherapy like nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems; as well as specific risks from radioembolization such as abdominal pain or potential damage to non-target organs.

CapTemY90 Trial Eligibility Criteria

Inclusion Criteria

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

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I have a grade 2 neuroendocrine tumor with liver metastases that cannot be surgically removed.

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My main portal vein is open and not blocked.

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I have a liver tumor larger than 1cm that can be measured.

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My liver cancer affects less than half of my liver.

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I am older than 18 years.

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Half or more of my cancer is in my liver.

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My liver is functioning well, based on recent tests.

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My blood platelets, kidney function, and blood clotting levels are within the required range.

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I can take care of myself and perform daily activities.

CapTemY90 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

intra-hepatic progression-free survival

Secondary outcome measures

Chromogrannin A level

EORTC QLQ-GINET21

Intra-hepatic and extra-hepatic tumor responses

+2 more

CapTemY90 Trial Design

1Treatment groups

Experimental Treatment

Group I: CapTemY90Experimental Treatment1 Intervention

Capecitabine 600 mg/m2 twice daily for 14 days and temozolomide 150-200 mg/m2 in two divided doses on Days 10-14, with 14 days between cycles, to be continued until 1) disease progression or 2) intolerable toxicities. During the initial cycle of CapTem, simulation angiography for Y-90 radioembolization planning will be performed. Once the patient has successfully completed the first cycle of CapTem and undergone simulation demonstrating eligibility for Y-90 radioembolization, the dominant lobe will be treated on Day 7 of the 2nd cycle of CapTem. Resin microspheres will be prescribed according to the BSA method per the manufacturer's Instructions for Use. If the other hepatic lobe needs to be treated, this will be done on Day 7 of the 3rd or 4th cycle of CapTem.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor

359 Previous Clinical Trials

105,009 Total Patients Enrolled

2 Trials studying Neuroendocrine Tumors

212 Patients Enrolled for Neuroendocrine Tumors

Roswell Park Cancer InstituteOTHER

402 Previous Clinical Trials

30,752 Total Patients Enrolled

4 Trials studying Neuroendocrine Tumors

228 Patients Enrolled for Neuroendocrine Tumors

CARTIUNKNOWN

2 Previous Clinical Trials

550 Total Patients Enrolled

1 Trials studying Neuroendocrine Tumors

50 Patients Enrolled for Neuroendocrine Tumors

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04789109 — Phase 2

Neuroendocrine Tumors Research Study Groups: CapTemY90

Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04789109 — Phase 2

Neuroendocrine Tumors Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT04789109 — Phase 2

Frequently Asked Questions

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

Are the combination of Capecitabine tablets, temozolomide tablets, and SIR-Spheres supported by a federal stamp of approval?

"On the basis of Phase 2 data, our team at Power rated capecitabine tablets + temozolomide tablets + SIR-Spheres a score of two for safety; albeit there is evidence to support its security, no studies have confirmed its efficacy."

Answered by AI

Are there any reports detailing the effects of taking Capecitabine tablets in combination with temozolomide tablets and SIR-Spheres?

"Currently, 531 studies involving the combination of Capecitabine tablets + temozolomide tablets + SIR-Spheres are actively recruiting participants. Of these trials, 149 have reached Phase 3 and a total of 16,516 locations across the world are running them. Adelaide in South Australia is among the sites hosting these investigations."

Answered by AI

Is this experimental protocol new to the field?

"Since 2002, comprehensive research has been conducted into the effects of Capecitabine tablets + temozolomide tablets + SIR-Spheres. The initial trial was funded by Schering-Plough and involved 60 participants—prompting Phase 2 drug approval in due course. Nowadays, 531 active studies are taking place across 70 nations and 2291 cities."

Answered by AI

Are researchers currently looking for volunteers to join this experiment?

"Affirmative. Clinicaltrials.gov reveals that this research endeavour, first posted on November 1st 2021, is seeking volunteers at present. The clinical trial requires 55 individuals to register from a single medical centre."

Answered by AI

How many individuals are enrolled in this investigation?

"Affirmative. clinicaltrials.gov has the latest information on this medical investigation, which was originally posted in November 2021 and last modified in October of that same year. The exploration is seeking 55 individuals to participate at a single trial centre."

Answered by AI

What disease or condition would necessitate treatment with Capecitabine tablets, temozolomide tablets and SIR-Spheres?

"For managing progression of the illness, Capecitabine tablets + temozolomide tablets + SIR-Spheres is often recommended. Additionally, this combination can be advantageous for patients dealing with nitrosourea treatment, advance directives and refractory advanced mycosis fungoides."

Answered by AI

Recent research and studies

PancreasJournal

Safety and Feasibility of Integrating Yttrium-90 Radioembolization with Capecitabine-temozolomide for Grade 2 Liver-dominant Metastatic Neuroendocrine Tumors

Soulen, Michael C., Diana van Houten, Ursina R. Teitelbaum, Nevena Damjanov, Keith A. Cengel, and David C. Metz. 2018. “Safety and Feasibility of Integrating Yttrium-90 Radioembolization with Capecitabine-temozolomide for Grade 2 Liver-dominant Metastatic Neuroendocrine Tumors”. Pancreas. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mpa.0000000000001115.

clinicaltrials.govStudy

CapTem Plus Radioembolization for NET Liver Metastases

Micheal C Soulen, MD 2021. "CapTem Plus Radioembolization for NET Liver Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04789109.

All > Liver Cancer > Neuroendocrine Tumor