Radioactive therapy vs chemotherapy: which works better for pancreatic NETs?
NCT ID NCT05247905
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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31 people
The number who actually took part.
- Started
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Feb 2023
- Expected to finish
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Oct 2033
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014, United States
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AMG Libertyville - Oncology
Libertyville, Illinois, 60048, United States
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Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
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Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515, United States
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Advocate Good Shepherd Hospital
Barrington, Illinois, 60010, United States
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Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
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Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
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Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506, United States
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Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois, 60453, United States
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Advocate Sherman Hospital
Elgin, Illinois, 60123, United States
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Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429, United States
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Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
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Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
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Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
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Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
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Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
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Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209, United States
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Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
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Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
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Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
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Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022, United States
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Aurora Health Center - Greenfield
Greenfield, Wisconsin, 53228, United States
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Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
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Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
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Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110, United States
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Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
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Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
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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
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Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671, United States
-
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
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Bay Area Breast Surgeons Inc
Emeryville, California, 94608, United States
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Bay Area Tumor Institute
Oakland, California, 94609, United States
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Boston Medical Center
Boston, Massachusetts, 02118, United States
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Boulder Community Foothills Hospital
Boulder, Colorado, 80303, United States
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Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
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Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
-
Cancer Partners of Nebraska
Lincoln, Nebraska, 68516, United States
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Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
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Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
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Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
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Condell Memorial Hospital
Libertyville, Illinois, 60048, United States
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Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
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Crossroads Cancer Center
Effingham, Illinois, 62401, United States
-
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
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Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
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Epic Care Cyberknife Center
Walnut Creek, California, 94597, United States
-
Epic Care Partners in Cancer Care
Emeryville, California, 94608, United States
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Epic Care-Dublin
Dublin, California, 94568, United States
-
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
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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
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Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
-
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
-
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
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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
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Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
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Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
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Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
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Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
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Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
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Jefferson Healthcare
Port Townsend, Washington, 98368, United States
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Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025, United States
-
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
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MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109, United States
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Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
-
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
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Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401, United States
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Marshfield Medical Center - Ladysmith
Ladysmith, Wisconsin, 54848, United States
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Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
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Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
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Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
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Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
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Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
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Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
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Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054, United States
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Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Memorial Hospital of Carbondale
Carbondale, Illinois, 62902, United States
-
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703, United States
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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
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Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
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Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
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Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
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Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461, United States
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Mount Sinai Hospital
New York, New York, 10029, United States
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Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113, United States
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Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123, United States
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Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118, United States
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Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
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Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
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Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
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Northwestern Medicine Orland Park
Orland Park, Illinois, 60462, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
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Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
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Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
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Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
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Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
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Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
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Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
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Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
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Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
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Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
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Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112, United States
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Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113, United States
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Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012, United States
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Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
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Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228, United States
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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
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Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124, United States
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Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260, United States
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SIH Cancer Institute
Carterville, Illinois, 62918, United States
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Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
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Saint Vincent Hospital
Erie, Pennsylvania, 16544, United States
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Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
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Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
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Sanford Cancer Center Worthington
Worthington, Minnesota, 56187, United States
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Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
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Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
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Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437, United States
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Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385, United States
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Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, 02891, United States
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Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033, United States
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Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830, United States
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Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, 06902, United States
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Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
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Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824, United States
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Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
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Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418, United States
-
Smilow Cancer Hospital-Orange Care Center
Orange, Connecticut, 06477, United States
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Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790, United States
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Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708, United States
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Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
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Springfield Clinic
Springfield, Illinois, 62702, United States
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Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
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State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
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The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113, United States
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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
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Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505, United States
-
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
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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
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Valley Radiation Oncology
Peru, Illinois, 61354, United States
-
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
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Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
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Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
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West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
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Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
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Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090, United States
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Yale University
New Haven, Connecticut, 06520, United States
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Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473, United States
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