Radioactive therapy vs chemotherapy: which works better for pancreatic NETs?

NCT ID NCT05247905

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial compares two treatment approaches for pancreatic neuroendocrine tumors that have spread or cannot be removed surgically. One group receives lutetium Lu 177 dotatate, a radioactive drug that targets tumor cells, while the other receives a combination of chemotherapy drugs, capecitabine and temozolomide. Researchers want to see which approach better delays tumor growth. The study includes adults with well-differentiated tumors, a type that tends to grow more slowly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lutetium Lu 177 dotatate (a radioactive drug that targets tumor cells) compared with capecitabine and temozolomide (chemotherapy drugs)
What this could lead to
If it works, this could point toward a more effective first-line treatment for advanced pancreatic neuroendocrine tumors, potentially delaying tumor growth better than current chemotherapy.
What could go wrong
This is a phase II trial with a small number of participants, so results may not be definitive. The radioactive drug can affect healthy tissues, and chemotherapy has side effects; either treatment may not prove superior.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

31 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Oct 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologic or pathologic documentation: well-differentiated pancreatic neuroendocrine tumor (G1, G2, or well-differentiated G3) confirmed by local histology and/or pathology * Functional or nonfunctional tumors are allowed * Patients with poorly differentiated neuroendocrine carcinoma (including large cell histology or small cell histology) are not eligible * Stage: locally unresectable or metastatic disease * Tumor Site: neuroendocrine tumor of pancreatic primary site * Radiologic evaluation: tumor must have shown somatostatin receptor (SSTR) positivity on 68Ga-DOTATATE PET or other SSTR-PET scan in the 12 months prior to registration; however, documentation of SSTR positivity in the 6 months prior to registration is preferred. SSTR positivity is defined as uptake greater than background liver in all measurable lesions * Patients are eligible if they meet one of the following criteria: * Previously untreated patients with grade 2 or 3 disease AND with symptoms of either disease bulk causing pain, anorexia, early satiety, large effusions/ascites, abdominal pain, abdominal fullness due to hepatomegaly, dyspnea) OR incompletely controlled symptoms of hormone excess despite somatostatin analogue (SSA) and supportive care (including but not limited to: diarrhea, hypercalcemia, hypoglycemia, hyperglycemia, flushing, Cushing's syndrome). Patient may have been started on SSA for up to 2 months for attempted symptom control without disease progression prior to registration * Patients previously treated with SSA only * Any patient with disease progression by RECIST criteria in \< 4 months * Patients must have measurable disease per RECIST v1.1 by computer tomography (CT) scan or magnetic imaging (MRI). Any lesions which have undergone percutaneous therapies or radiotherapy after starting protocol therapy should not be considered measurable unless the lesion has clearly progressed since the procedure. \* Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 1 cm with CT or MRI (or shortest diameter \>= 1.5 cm for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly non- measurable including: leptomeningeal disease, bone metastases, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung. * No prior temozolomide, dacarbazine, capecitabine, 5-FU, or any PRRT for treatment of the pNET * Prior treatment with tyrosine kinase inhibitors (TKIs) such as mammalian target of rapamycin (mTOR) inhibitors (e.g. everolimus, temsirolimus, etc.) or VEGF pathway inhibitors (e.g. sunitinib, pazopanib, cabozantinib, bevacizumab, etc.) are allowed * Prior treatment with hepatic intra-arterial embolic therapies is allowed if there is recovery from all toxicities, measurable lesions do not include embolized liver unless there has been clear subsequent progression, all measurable lesions are somatostatin receptor avid, and treatment completed at least 2 months prior to registration * Prior treatment with cryoablation or thermal/radiofrequency ablation of metastases is allowed if there is recovery from all toxicities, measurable lesions do not include treated metastases, and treatment completed at least 2 months prior to registration * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects \* Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 9.0 g/dL * Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \>= 30 mL/min (calculated by the Cockcroft-Gault equation) * Total bilirubin =\< 1.5 x ULN (in patients with liver metastases or known Gilbert's syndrome, total bilirubin must be =\< 3.0 x ULN) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x ULN * Albumin \>= 3.0 g/dL * No known brain metastases unless adequately treated, demonstrated to be stable, and off all treatment (including steroids) for at least 2 months prior to registration * No uncontrolled congestive heart failure (New York Heart Association \[NYHA\] II, III, IV). * No significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may pose a risk to patient safety * No "currently active" second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy or are on adjuvant hormonal therapy and are free of disease for \>= 3 years * No known medical condition causing an inability to swallow and no known impairment of gastrointestinal function that may significantly alter the absorption of an oral agent * Concurrent somatostatin analog use while on protocol therapy is allowed provided that the patient: * Has a functional tumor (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome) * Has been on a stable dose of somatostatin analog therapy for at least three months * Has previously demonstrated radiographic disease progression while on somatostatin analog therapy. For subjects receiving lutetium Lu 177 dotatate, there should be a minimum of 28 days between long-acting somatostatin analogue and lutetium Lu 177 dotatate dosing. Short-acting somatostatin analogs should not be administered within 24 hours of lutetium Lu 177 dotatate dosing. Following lutetium Lu 177 dotatate dosing, long-acting somatostatin analogs may be administered between 4 and 24 hours after each dose

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014, United States

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048, United States

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699, United States

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515, United States

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010, United States

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657, United States

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068, United States

  • Advocate Outpatient Center - Aurora

    Aurora, Illinois, 60506, United States

  • Advocate Outpatient Center - Oak Lawn

    Oak Lawn, Illinois, 60453, United States

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123, United States

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143, United States

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311, United States

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024, United States

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142, United States

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209, United States

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226, United States

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406, United States

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105, United States

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022, United States

  • Aurora Health Center - Greenfield

    Greenfield, Wisconsin, 53228, United States

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066, United States

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110, United States

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233, United States

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227, United States

  • BASS Medical Group - Lennon

    Walnut Creek, California, 94598, United States

  • BJC Outpatient Center at Sunset Hills

    Sunset Hills, Missouri, 63127, United States

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017, United States

  • Baptist Memorial Hospital and Cancer Center-Desoto

    Southhaven, Mississippi, 38671, United States

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120, United States

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608, United States

  • Bay Area Tumor Institute

    Oakland, California, 94609, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Boulder Community Foothills Hospital

    Boulder, Colorado, 80303, United States

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269, United States

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526, United States

  • Cancer Partners of Nebraska

    Lincoln, Nebraska, 68516, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Condell Memorial Hospital

    Libertyville, Illinois, 60048, United States

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156, United States

  • Crossroads Cancer Center

    Effingham, Illinois, 62401, United States

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756, United States

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526, United States

  • Epic Care Cyberknife Center

    Walnut Creek, California, 94597, United States

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608, United States

  • Epic Care-Dublin

    Dublin, California, 94568, United States

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701, United States

  • Forbes Hospital

    Monroeville, Pennsylvania, 15146, United States

  • Hickman Cancer Center

    Adrian, Michigan, 49221, United States

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • Illinois CancerCare - Washington

    Washington, Illinois, 61571, United States

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704, United States

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520, United States

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321, United States

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021, United States

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530, United States

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401, United States

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443, United States

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455, United States

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350, United States

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554, United States

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615, United States

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354, United States

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356, United States

  • Jefferson Healthcare

    Port Townsend, Washington, 98368, United States

  • Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025, United States

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287, United States

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109, United States

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494, United States

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729, United States

  • Marshfield Clinic-Wausau Center

    Wausau, Wisconsin, 54401, United States

  • Marshfield Medical Center - Ladysmith

    Ladysmith, Wisconsin, 54848, United States

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548, United States

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476, United States

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701, United States

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449, United States

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868, United States

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482, United States

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902, United States

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703, United States

  • Mercy Health - Paducah Cancer Center

    Paducah, Kentucky, 42003, United States

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636, United States

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131, United States

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080, United States

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467, United States

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461, United States

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113, United States

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123, United States

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118, United States

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640, United States

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218, United States

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605, United States

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640, United States

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615, United States

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605, United States

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650, United States

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672, United States

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316, United States

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605, United States

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112, United States

  • Rocky Mountain Cancer Centers - Swedish

    Englewood, Colorado, 80113, United States

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012, United States

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304, United States

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228, United States

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120, United States

  • Rocky Mountain Cancer Centers-Longmont

    Longmont, Colorado, 80501, United States

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218, United States

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220, United States

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124, United States

  • Rocky Mountain Cancer Centers-Thornton

    Thornton, Colorado, 80260, United States

  • SIH Cancer Institute

    Carterville, Illinois, 62918, United States

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703, United States

  • Saint Vincent Hospital

    Erie, Pennsylvania, 16544, United States

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670, United States

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104, United States

  • Sanford Cancer Center Worthington

    Worthington, Minnesota, 56187, United States

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134, United States

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016, United States

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437, United States

  • Smilow Cancer Hospital Care Center - Waterford

    Waterford, Connecticut, 06385, United States

  • Smilow Cancer Hospital Care Center - Westerly

    Westerly, Rhode Island, 02891, United States

  • Smilow Cancer Hospital Care Center at Glastonbury

    Glastonbury, Connecticut, 06033, United States

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830, United States

  • Smilow Cancer Hospital Care Center at Long Ridge

    Stamford, Connecticut, 06902, United States

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105, United States

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824, United States

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611, United States

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418, United States

  • Smilow Cancer Hospital-Orange Care Center

    Orange, Connecticut, 06477, United States

  • Smilow Cancer Hospital-Torrington Care Center

    Torrington, Connecticut, 06790, United States

  • Smilow Cancer Hospital-Waterbury Care Center

    Waterbury, Connecticut, 06708, United States

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702, United States

  • Springfield Clinic

    Springfield, Illinois, 62702, United States

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781, United States

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210, United States

  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113, United States

  • The Women's Imaging Center

    Denver, Colorado, 80209, United States

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537, United States

  • Toledo Clinic Cancer Centers-Monroe

    Monroe, Michigan, 48162, United States

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623, United States

  • Torrance Memorial Physician Network - Cancer Care

    Torrance, California, 90505, United States

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211, United States

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451, United States

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462, United States

  • University of Illinois

    Chicago, Illinois, 60612, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • Valley Radiation Oncology

    Peru, Illinois, 61354, United States

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904, United States

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081, United States

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241, United States

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224, United States

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401, United States

  • Wexford Health and Wellness Pavilion

    Wexford, Pennsylvania, 15090, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473, United States

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