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Alkylating agents
CapTem + Y90 for Neuroendocrine Cancer (CapTemY90 Trial)
Phase 2
Recruiting
Led By Michael Soulen
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Liver tumor burden does not exceed 50% of the liver volume
Patients with confirmed diagnosis of histologic grade 2 neuroendocrine tumor with unresectable liver metastases (primary tumor or other extrahepatic disease may be present)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years. from time of initiation of study therapy until subject comes off of study, or study closes
Awards & highlights
CapTemY90 Trial Summary
This trial is testing if a combination of two treatments is more effective than either treatment alone in preventing the progression of liver metastases in patients with neuroendocrine tumors.
Who is the study for?
Adults over 18 with Grade 2 neuroendocrine tumors and liver metastases that can't be removed by surgery. They should have a life expectancy of more than 6 months, stable health, and not have had chemotherapy or radiotherapy in the last 4 weeks. Liver function must be within certain limits, and they need to use effective contraception if capable of childbearing.Check my eligibility
What is being tested?
The trial is testing how well patients with specific liver tumors respond to a combination therapy using Capecitabine, Temozolomide (oral medications), and Y90 radioembolization compared to previous treatments. It's a Phase 2 study focusing on whether this mix can safely improve disease control.See study design
What are the potential side effects?
Possible side effects include those common to chemotherapy like nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Radioembolization may cause abdominal pain or fever. Specific risks will depend on individual patient factors.
CapTemY90 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Less than half of my liver is affected by cancer.
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I have a grade 2 neuroendocrine tumor with liver metastases that cannot be surgically removed.
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My liver is working well, based on recent tests.
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My blood platelets, kidney function, and blood clotting levels are within the required ranges.
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My main portal vein is open and unblocked.
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I am older than 18 years.
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Half or more of my cancer is in my liver.
Select...
I can take care of myself and am up and about more than half of the day.
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I have a liver tumor larger than 1cm that can be measured.
CapTemY90 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years. from time of initiation of study therapy until subject comes off of study, or study closes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years. from time of initiation of study therapy until subject comes off of study, or study closes
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
Change in CgA over time
Intra-hepatic tumor responses by EASL
Intra-hepatic tumor responses by RECIST
+5 moreCapTemY90 Trial Design
1Treatment groups
Experimental Treatment
Group I: Oral CapTem + Y90 RadioembolizationExperimental Treatment3 Interventions
Capecitabine 750 mg/m2 twice daily orally for 14 days and temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles, to be continued until 1) disease progression or 2) intolerable toxicities.
Trans-arterial radioembolization (TARE) on Day 7 of cycle 2 and, if needed for the other lobe, Day 7 of either cycle 3 or 4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine Oral Product
2011
Completed Phase 3
~70
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,002 Previous Clinical Trials
42,880,819 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
1,161 Patients Enrolled for Neuroendocrine Tumors
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,484 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
174 Patients Enrolled for Neuroendocrine Tumors
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
104,884 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
217 Patients Enrolled for Neuroendocrine Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Less than half of my liver is affected by cancer.I have a grade 2 neuroendocrine tumor with liver metastases that cannot be surgically removed.My liver is working well, based on recent tests.My blood platelets, kidney function, and blood clotting levels are within the required ranges.I cannot take capecitabine or temozolomide due to adverse reactions.It has been over 4 weeks since my last chemo or radiation treatment.I cannot have a specific liver cancer treatment due to high risk of complications.I cannot have IV contrast due to a severe past reaction.My main portal vein is open and unblocked.I am older than 18 years.I have had surgery or a procedure to treat bile duct blockage.I am using effective birth control or have confirmed I am not pregnant.Half or more of my cancer is in my liver.I have had treatment with transarterial embolization or radioembolization.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I can take care of myself and am up and about more than half of the day.I have a liver tumor larger than 1cm that can be measured.
Research Study Groups:
This trial has the following groups:- Group 1: Oral CapTem + Y90 Radioembolization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical applications does transarterial radioembolization typically target?
"Transarterial radioembolization is the favoured treatment method for progressive disease. This therapy can also be applied to other medical conditions including nitrosourea-resistant cancers, end of life planning, and refractory cases of mycosis fungoides."
Answered by AI
What risks are associated with transarterial radioembolization?
"Considering the Phase 2 label, which suggests that there is only limited efficacy data available, transarterial radioembolization was assigned a score of 2 for safety."
Answered by AI
What is the uppermost threshold of participants in this experiment?
"This medical trial requires 50 suitable participants, and patient recruitment is occurring at the University of Pennsylvania in Philadelphia and CARTI Cancer Center in Little Rock."
Answered by AI
Is this research recruitment still open?
"Affirmative. Clinicaltrials.gov's information demonstrates that the study is presently searching for participants, with a commencement date of October 7th 2021 and most recent update occurring on August 11 2022. The medical trial requires 50 patients from 3 different healthcare facilities."
Answered by AI
Is this a groundbreaking trial that has never been seen before?
"Since the initial 2002 trial sponsored by Schering-Plough and featuring 60 patients, transarterial radioembolization has been studied extensively. Currently, there are 531 ongoing trials for this procedure located in 2291 cities over 70 countries worldwide which have seen it receive Phase 2 drug approval."
Answered by AI
What precedent has been set by other research projects utilizing transarterial radioembolization?
"Transarterial radioembolization was trialled for the first time in 2002 at Memorial Sloan Kettering Cancer Center, with 844 trials having since been completed. Currently 531 active studies are recruiting patients, and a vast proportion of these are situated within Philadelphia, Pennsylvania."
Answered by AI
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