Neuroendocrine Tumor Grade 2Phase 2CapTemY90NCT04339036
CapTemY90 for Grade 2/3 NET Liver Metastases
A Phase 2 study testing Capecitabine Oral Product, Temozolomide Oral Product and transarterial radioembolization in people with Neuroendocrine Tumor Grade 2 and Neuroendocrine Tumors, run by Abramson Cancer Center at Penn Medicine at 5 sites in United States.
Trial summary
This is a Phase 2 evaluation of hepatic-progression free survival among patients with Grade 2 liver-dominant NET metastases undergoing combination therapy with CapTem and Y90 radioembolization.The hypothesis is to confirm safety and to assess if disease control is improved relative to expectation from either therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumor Grade 2, Neuroendocrine Tumors
- What is being tested?
- Capecitabine Oral Product, Temozolomide Oral Product and transarterial radioembolization
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Oct 2021to 1 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed diagnosis of histologic grade 2 or 3 well differentiated neuroendocrine tumor with unresectable liver metastases (primary tumor or other extrahepatic disease may be present)
- Patients with at least one measurable liver metastases, with size > 1cm (RECIST criteria)
- Patients with liver dominant disease defined as ≥50% tumor body burden confined to the liver
- Liver tumor burden does not exceed 50% of the liver volume
- Patent main portal vein
- At least 4 weeks since last administration of last chemotherapy and /or radiotherapy
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- Age >18 years.
- Life expectancy of greater than 6 months.
- ECOG performance status 0-2.
- Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl.
- Patients must have adequate organ and marrow function as defined below:
- platelets >100,000/mcL (may be corrected by transfusion)
- serum creatinine < 2.0 mg/dl
- INR <1.6, (may be corrected by transfusion)
- Ability to understand and the willingness to sign a written informed consent document.
- Women of child bearing potential and fertile men are required to use effective contraception (negative urine or serum βHCG for women of child-bearing age)
Who cannot join
- Contraindications to capecitibine or temozolomide
- Contraindicated for both contrast-enhanced MRI and CT
- Patients previously treated with transarterial embolization (with or without chemotherapy) or with radioembolization (Y-90 microspheres)
- Contraindication for radioembolization procedures:
- excessive hepatopulmonary shunt as determined by the investigator
- inability to deliver Y90 microspheres without risk of non-target embolization of extra-hepatic structures
Show all 12Show fewer
- Subjects consenting to the trial who fail their simulation angiography will be removed from the study and replaced.
- Patients may not be receiving any other investigational agents.
- Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication).
- Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla;
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and lactating women are ineligible
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Veronica Faris contact
5 sites in 1 country
United States5 sites, 1 recruiting
- Active, not recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
- Active, not recruiting
UC San Diego
La Jolla, California, 92037
- Active, not recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
- Active, not recruiting
UM Sylvester Comprehensive Cancer Center at Plantation
Miami, Florida, 33324
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19103
Veronica Faris, 215-746-7050, veronica.faris@pennmedicine.upenn.edu
Michael Soulen, MD
About this study
Official title: UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2/3 Neuroendocrine Tumors
This is a Phase 2 evaluation of hepatic-progression free survival among patients with Grade 2 liver-dominant NET metastases undergoing combination therapy with CapTem and Y90 radioembolization.The hypothesis is to confirm safety and to assess if disease control is improved relative to expectation from either therapy alone.
A Grade 3 arm was added in 2025.
Read the detailed description
Patients with liver-dominant Grade 2/3 NET metastases from any primary will start CapTem and undergo simulation angiography for radioembolization planning during the first cycle. If they tolerate CapTem and are not excluded from radioembolization, then TARE will be performed on Day 7 of Cycle 2, with additional TARE of Day 7 of cycle 3 or 4 as needed to treat the entire tumor burden. Patients will remain on CapTem until progression or intolerance.
Primary outcome measure is hepatic progression-free survival.
- Being tested
- Capecitabine Oral Product, Temozolomide Oral Product, transarterial radioembolization
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine Oral ProductDrug
Also called Xeloda
Capecitabine 750 mg/m2 twice daily orally for 14 days
Temozolomide Oral ProductDrug
Also called Temodar
temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles
transarterial radioembolizationCombination product
Also called TARE, y90
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral CapTem + Y90 Radioembolization | Experimental | 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. Receives: Drug: Capecitabine Oral Product; Drug: Temozolomide Oral Product; Combination Product: transarterial radioembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-hepatic progression-free survival
Intra-hepatic progression-free survival by RECIST 1.0 is defined as the time from initiation of study therapy until first documented intra-hepatic disease progression, death due to any cause or last scan date that documented intra-hepatic progression-free status.
Measured: 2 years. Time from initiation of study therapy until first documented intra-hepatic disease progression, death due to any cause or last scan date that documented intra-hepatic progression-free status.
Secondary outcomes (8)
Overall Progression free survival
Overall progression-free survival is defined as the time from initiation of study therapy until first documented intra- or extra-hepatic disease progression, death due to any cause or last scan date that documented progression-free status
Measured: 2 years. time from initiation of study therapy until first documented intra- or extra-hepatic disease progression, death due to any cause or last scan date that documented progression-free status
Intra-hepatic tumor responses by RECIST
Intra-hepatic tumor responses will be evaluated by RECIST.
Measured: 2 years. from time of initiation of study therapy until subject comes off of study, or study closes
Intra-hepatic tumor responses by EASL
Intra-hepatic tumor responses will be evaluated by EASL criteria.
Measured: 2 years. from time of initiation of study therapy until subject comes off of study, or study closes
extra-hepatic tumor responses
extra-hepatic tumor responses will be evaluated by RECIST.
Measured: 2 years. from time of initiation of study therapy until subject comes off of study, or study closes
Number of participants with systemic toxicities
Systemic toxicities will be individually assessed by NCI CTCAE Version 4.
Measured: From period of enrollment to 24 months after last treatment
Number of participants with hepatic toxicities
Hepatic toxicities will be individually assessed by NCI CTCAE Version 4.
Measured: From period of enrollment to 24 months after last treatment
Change in CgA over time
The primary marker is CgA. Additional cancer site-specific (i.e., gastrinoma) markers may also be assayed.
Measured: Tumor markers will be assessed at baseline and then every 3 months for 24 months.
Quality of Life by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Neuroendocrine tumor
Quality of Life will be measure by a validated NET-specific instrument, EORTC. Scale is 0-100, higher scores indicate worse symptoms/functioning
Measured: Quality of life will be measured at baseline and then every 3 months for 24 months .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start7 Oct 2021
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine Tumor Grade 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Soulen, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339036
- Sponsor's protocol ID
- UPCC 04219
- Other IDs
- 04219
- Acronym
- CapTemY90
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2020
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Modlin IM, Moss SF, Chung DC, Jensen RT, Snyderwine E. Priorities for improving the management of gastroenteropancreatic neuroendocrine tumors. J Natl Cancer Inst. 2008 Sep 17;100(18):1282-9. doi: 10.1093/jnci/djn275. Epub 2008 Sep 9.
PubMed 18780869Norheim I, Oberg K, Theodorsson-Norheim E, Lindgren PG, Lundqvist G, Magnusson A, Wide L, Wilander E. Malignant carcinoid tumors. An analysis of 103 patients with regard to tumor localization, hormone production, and survival. Ann Surg. 1987 Aug;206(2):115-25. doi: 10.1097/00000658-198708000-00001.
PubMed 2440390Talamonti MS, Stuart K, Yao JC. Neuroendocrine tumors of the gastrointestinal tract: how aggressive should we be? In: Perry M, ed. American Society of Clinical Oncology 2004 Education Book. Alexandria: American Society of Clinical Oncology, 2004;206-215.
Arnold R, Trautmann ME, Creutzfeldt W, Benning R, Benning M, Neuhaus C, Jurgensen R, Stein K, Schafer H, Bruns C, Dennler HJ. Somatostatin analogue octreotide and inhibition of tumour growth in metastatic endocrine gastroenteropancreatic tumours. Gut. 1996 Mar;38(3):430-8. doi: 10.1136/gut.38.3.430.
PubMed 8675099Saltz L, Trochanowski B, Buckley M, Heffernan B, Niedzwiecki D, Tao Y, Kelsen D. Octreotide as an antineoplastic agent in the treatment of functional and nonfunctional neuroendocrine tumors. Cancer. 1993 Jul 1;72(1):244-8. doi: 10.1002/1097-0142(19930701)72:13.0.co;2-q.
PubMed 8389666Rinke A, Muller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Blaker M, Harder J, Arnold C, Gress T, Arnold R; PROMID Study Group. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009 Oct 1;27(28):4656-63. doi: 10.1200/JCO.2009.22.8510. Epub 2009 Aug 24.
PubMed 19704057Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.
PubMed 25014687Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Van Cutsem E, Hobday TJ, Okusaka T, Capdevila J, de Vries EG, Tomassetti P, Pavel ME, Hoosen S, Haas T, Lincy J, Lebwohl D, Oberg K; RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3) Study Group. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):514-23. doi: 10.1056/NEJMoa1009290.
PubMed 21306238Raymond E, Dahan L, Raoul JL, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Horsch D, Hammel P, Wiedenmann B, Van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):501-13. doi: 10.1056/NEJMoa1003825.
PubMed 21306237Gaba RC. Chemoembolization practice patterns and technical methods among interventional radiologists: results of an online survey. AJR Am J Roentgenol. 2012 Mar;198(3):692-9. doi: 10.2214/AJR.11.7066.
PubMed 22358011Kennedy AS, Dezarn WA, McNeillie P, Coldwell D, Nutting C, Carter D, Murthy R, Rose S, Warner RR, Liu D, Palmedo H, Overton C, Jones B, Salem R. Radioembolization for unresectable neuroendocrine hepatic metastases using resin 90Y-microspheres: early results in 148 patients. Am J Clin Oncol. 2008 Jun;31(3):271-9. doi: 10.1097/COC.0b013e31815e4557.
PubMed 18525307Saxena A, Chua TC, Bester L, Kokandi A, Morris DL. Factors predicting response and survival after yttrium-90 radioembolization of unresectable neuroendocrine tumor liver metastases: a critical appraisal of 48 cases. Ann Surg. 2010 May;251(5):910-6. doi: 10.1097/SLA.0b013e3181d3d24a.
PubMed 20395859Memon K, Lewandowski RJ, Mulcahy MF, Riaz A, Ryu RK, Sato KT, Gupta R, Nikolaidis P, Miller FH, Yaghmai V, Gates VL, Atassi B, Newman S, Omary RA, Benson AB 3rd, Salem R. Radioembolization for neuroendocrine liver metastases: safety, imaging, and long-term outcomes. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):887-94. doi: 10.1016/j.ijrobp.2011.07.041. Epub 2011 Dec 2.
PubMed 22137020Pavel M, Baudin E, Couvelard A, Krenning E, Oberg K, Steinmuller T, Anlauf M, Wiedenmann B, Salazar R; Barcelona Consensus Conference participants. ENETS Consensus Guidelines for the management of patients with liver and other distant metastases from neuroendocrine neoplasms of foregut, midgut, hindgut, and unknown primary. Neuroendocrinology. 2012;95(2):157-76. doi: 10.1159/000335597. Epub 2012 Feb 15. No abstract available.
PubMed 22262022Strosberg JR, Fine RL, Choi J, Nasir A, Coppola D, Chen DT, Helm J, Kvols L. First-line chemotherapy with capecitabine and temozolomide in patients with metastatic pancreatic endocrine carcinomas. Cancer. 2011 Jan 15;117(2):268-75. doi: 10.1002/cncr.25425. Epub 2010 Sep 7.
PubMed 20824724
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2/3 Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT04339036
- Acronym / sponsor ID
- CapTemY90 / UPCC 04219
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 evaluation of hepatic-progression free survival among patients with Grade 2 liver-dominant NET metastases undergoing combination therapy with CapTem and Y90 radioembolization.The hypothesis is to confirm safety and to assess if disease control is improved relative to expectation from either therapy alone.
A Grade 3 arm was added in 2025.
Detailed description
Patients with liver-dominant Grade 2/3 NET metastases from any primary will start CapTem and undergo simulation angiography for radioembolization planning during the first cycle. If they tolerate CapTem and are not excluded from radioembolization, then TARE will be performed on Day 7 of Cycle 2, with additional TARE of Day 7 of cycle 3 or 4 as needed to treat the entire tumor burden. Patients will remain on CapTem until progression or intolerance.
Primary outcome measure is hepatic progression-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral CapTem + Y90 Radioembolization | Experimental | Drug: Capecitabine Oral Product, Drug: Temozolomide Oral Product, Combination Product: transarterial radioembolizationCapecitabine 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with confirmed diagnosis of histologic grade 2 or 3 well differentiated neuroendocrine tumor with unresectable liver metastases (primary tumor or other extrahepatic disease may be present)
- Patients with at least one measurable liver metastases, with size > 1cm (RECIST criteria)
- Patients with liver dominant disease defined as ≥50% tumor body burden confined to the liver
- Liver tumor burden does not exceed 50% of the liver volume
- Patent main portal vein
Key exclusion criteria (12 listed)
- Contraindications to capecitibine or temozolomide
- Contraindicated for both contrast-enhanced MRI and CT
- Patients previously treated with transarterial embolization (with or without chemotherapy) or with radioembolization (Y-90 microspheres)
- Contraindication for radioembolization procedures:
- excessive hepatopulmonary shunt as determined by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabine Oral ProductAlso: XelodaCapecitabine 750 mg/m2 twice daily orally for 14 days | Drug | Oral CapTem + Y90 Radioembolization |
| Temozolomide Oral ProductAlso: Temodartemozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles | Drug | Oral CapTem + Y90 Radioembolization |
| transarterial radioembolizationAlso: TARE, y90Trans-arterial radioembolization (TARE) on Day 7 of cycle 2 and, if needed for the other lobe, Day 7 of either cycle 3 or 4. | Combination product | Oral CapTem + Y90 Radioembolization |
Primary outcome
Intra-hepatic progression-free survival
Time frame: 2 years. Time from initiation of study therapy until first documented intra-hepatic disease progression, death due to any cause or last scan date that documented intra-hepatic progression-free status.
Intra-hepatic progression-free survival by RECIST 1.0 is defined as the time from initiation of study therapy until first documented intra-hepatic disease progression, death due to any cause or last scan date that documented intra-hepatic progression-free status.
8 secondary outcomes
Overall Progression free survival
Time frame: 2 years. time from initiation of study therapy until first documented intra- or extra-hepatic disease progression, death due to any cause or last scan date that documented progression-free status
Intra-hepatic tumor responses by RECIST
Time frame: 2 years. from time of initiation of study therapy until subject comes off of study, or study closes
Intra-hepatic tumor responses by EASL
Time frame: 2 years. from time of initiation of study therapy until subject comes off of study, or study closes
extra-hepatic tumor responses
Time frame: 2 years. from time of initiation of study therapy until subject comes off of study, or study closes
Number of participants with systemic toxicities
Time frame: From period of enrollment to 24 months after last treatment
Number of participants with hepatic toxicities
Time frame: From period of enrollment to 24 months after last treatment
Change in CgA over time
Time frame: Tumor markers will be assessed at baseline and then every 3 months for 24 months.
Quality of Life by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Neuroendocrine tumor
Time frame: Quality of life will be measured at baseline and then every 3 months for 24 months .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 18780869Modlin IM, Moss SF, Chung DC, Jensen RT, Snyderwine E. Priorities for improving the management of gastroenteropancreatic neuroendocrine tumors. J Natl Cancer Inst. 2008 Sep 17;100(18):1282-9. doi: 10.1093/jnci/djn275. Epub 2008 Sep 9.
- Background: PubMed 2440390Norheim I, Oberg K, Theodorsson-Norheim E, Lindgren PG, Lundqvist G, Magnusson A, Wide L, Wilander E. Malignant carcinoid tumors. An analysis of 103 patients with regard to tumor localization, hormone production, and survival. Ann Surg. 1987 Aug;206(2):115-25. doi: 10.1097/00000658-198708000-00001.
- BackgroundTalamonti MS, Stuart K, Yao JC. Neuroendocrine tumors of the gastrointestinal tract: how aggressive should we be? In: Perry M, ed. American Society of Clinical Oncology 2004 Education Book. Alexandria: American Society of Clinical Oncology, 2004;206-215.
- Background: PubMed 8675099Arnold R, Trautmann ME, Creutzfeldt W, Benning R, Benning M, Neuhaus C, Jurgensen R, Stein K, Schafer H, Bruns C, Dennler HJ. Somatostatin analogue octreotide and inhibition of tumour growth in metastatic endocrine gastroenteropancreatic tumours. Gut. 1996 Mar;38(3):430-8. doi: 10.1136/gut.38.3.430.
- Background: PubMed 8389666Saltz L, Trochanowski B, Buckley M, Heffernan B, Niedzwiecki D, Tao Y, Kelsen D. Octreotide as an antineoplastic agent in the treatment of functional and nonfunctional neuroendocrine tumors. Cancer. 1993 Jul 1;72(1):244-8. doi: 10.1002/1097-0142(19930701)72:13.0.co;2-q.
- Background: PubMed 19704057Rinke A, Muller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Blaker M, Harder J, Arnold C, Gress T, Arnold R; PROMID Study Group. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009 Oct 1;27(28):4656-63. doi: 10.1200/JCO.2009.22.8510. Epub 2009 Aug 24.
- Background: PubMed 25014687Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.
- Background: PubMed 21306238Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Van Cutsem E, Hobday TJ, Okusaka T, Capdevila J, de Vries EG, Tomassetti P, Pavel ME, Hoosen S, Haas T, Lincy J, Lebwohl D, Oberg K; RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3) Study Group. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):514-23. doi: 10.1056/NEJMoa1009290.
- Background: PubMed 21306237Raymond E, Dahan L, Raoul JL, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Horsch D, Hammel P, Wiedenmann B, Van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):501-13. doi: 10.1056/NEJMoa1003825.
- Background: PubMed 22358011Gaba RC. Chemoembolization practice patterns and technical methods among interventional radiologists: results of an online survey. AJR Am J Roentgenol. 2012 Mar;198(3):692-9. doi: 10.2214/AJR.11.7066.
- Background: PubMed 18525307Kennedy AS, Dezarn WA, McNeillie P, Coldwell D, Nutting C, Carter D, Murthy R, Rose S, Warner RR, Liu D, Palmedo H, Overton C, Jones B, Salem R. Radioembolization for unresectable neuroendocrine hepatic metastases using resin 90Y-microspheres: early results in 148 patients. Am J Clin Oncol. 2008 Jun;31(3):271-9. doi: 10.1097/COC.0b013e31815e4557.
- Background: PubMed 20395859Saxena A, Chua TC, Bester L, Kokandi A, Morris DL. Factors predicting response and survival after yttrium-90 radioembolization of unresectable neuroendocrine tumor liver metastases: a critical appraisal of 48 cases. Ann Surg. 2010 May;251(5):910-6. doi: 10.1097/SLA.0b013e3181d3d24a.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Veronica Faris contact
Michael Soulen principal investigator
University of Pennsylvania
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine Oral Product, Temozolomide Oral Product and transarterial radioembolization in people with Neuroendocrine Tumor Grade 2 and Neuroendocrine Tumors, run by Abramson Cancer Center at Penn Medicine at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Soulen, MD (855-216-0098, michael.soulen@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-hepatic progression-free survival (time frame: 2 years. Time from initiation of study therapy until first documented intra-hepatic disease progression, death due to any cause or last scan date that documented intra-hepatic progression-free status.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04339036, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.