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Could chemo before surgery boost gallbladder cancer survival?

NCT ID NCT04559139

Disease control Sponsor: ECOG-ACRIN Cancer Research Group Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This study looks at whether giving chemotherapy both before and after surgery helps people with stage II-III gallbladder cancer live longer compared to the usual approach of only giving chemo after surgery. About 186 participants will be randomly assigned to one of two groups. The goal is to see if the extra chemo before surgery can shrink the tumor and reduce the chance of cancer coming back.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 186 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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: * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Patient must have histologically-confirmed T2 or T3 gallbladder cancer discovered incidentally at the time of or following routine cholecystectomy for presumed benign disease * NOTE: Patients with histologically-confirmed Tis, T1a, T1b, or T4 tumors are not eligible * Patient must have undergone initial cholecystectomy within 12 weeks prior to randomization * Patient must have the ability to understand and the willingness to sign a written informed consent document * Leukocytes \>= 3,000/mcL (obtained =\< 28 days prior to randomization) * Absolute neutrophil count \>= 1,500/mcL (obtained =\< 28 days prior to randomization) * Platelets \>= 100,000/mcL (obtained =\< 28 days prior to randomization) * Total bilirubin =\< institutional upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome are eligible if direct bilirubin \< 1.5 x ULN of the direct bilirubin (obtained =\< 28 days prior to randomization) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained =\< 28 days prior to randomization) * Serum creatinine =\< institutional ULN OR creatinine clearance \>= 50 mL/min/1.73 m\^2 (Based on Cockcroft Gault estimation) (obtained =\< 28 days prior to randomization) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better Exclusion Criteria: * Patient must not have any evidence of metastatic disease or inoperable loco-regional disease based on high-quality, preoperative, cross-sectional imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) of the chest, abdomen, and pelvis (C/A/P) obtained within 6 weeks prior to randomization, defined as * No radiographic evidence of distant disease (M1 disease) * No radiographic evidence of tumor invasion into multiple extrahepatic organs (T4 disease) * No radiographic evidence of distant lymph node involvement (celiac, para-aortic, para-caval lymph nodes) * No evidence of new-onset ascites * Soft tissue thickening within or in direct communication with the gallbladder fossa, peri-portal lymph node involvement, involvement of one extrahepatic organ, and other disease within the confines of what constitutes 'localized resectable' disease are allowable * Women must not be pregnant or breast feeding due to the potential harm to unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 14 days prior to randomization. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Women of childbearing potential and sexually active males must not expect to conceive or father children by being strongly advised to use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study

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Conditions

The condition(s) this trial relates to.

gallbladder cancer gallbladder carcinoma gallbladder neoplasm

As listed by the trial registrant

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

Stage II gallbladder cancer ajcc V8 Stage IIA gallbladder cancer ajcc V8 Stage IIB gallbladder cancer ajcc V8 Stage III gallbladder cancer ajcc V8 Stage IIIA gallbladder cancer ajcc V8 Stage IIIB gallbladder cancer ajcc V8

Contacts and locations

Locations

  • Alaska Breast Care and Surgery LLC

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  • Albany Medical Center

    Albany, New York, 12208, United States

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    Omaha, Nebraska, 68124, United States

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    Omaha, Nebraska, 68130, United States

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    Council Bluffs, Iowa, 51503, United States

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    Findlay, Ohio, 45840, United States

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    Kalamazoo, Michigan, 49009, United States

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    Franklin, Ohio, 45005-1066, United States

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    Phoenix, Arizona, 85004, United States

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  • Carle Physician Group-Effingham

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    Mattoon, Illinois, 61938, United States

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    Los Angeles, California, 90048, United States

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    Bolivar, Missouri, 65613, United States

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    Great Bend, Kansas, 67530, United States

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    Centralia, Illinois, 62801, United States

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    Charleston, South Carolina, 29403, United States

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    Charleston, South Carolina, 29414, United States

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    Clackamas, Oregon, 97015, United States

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    Saint Joseph, Michigan, 49085, United States

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  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331, United States

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526, United States

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401, United States

  • Duke Cancer Institute Cary

    Cary, North Carolina, 27518, United States

  • Duke Raleigh Hospital

    Raleigh, North Carolina, 27609, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • East Carolina University

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  • Edward Hospital/Cancer Center

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  • Elmhurst Memorial Hospital

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  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342, United States

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

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    Atlanta, Georgia, 30322, United States

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004, United States

  • Franciscan Research Center-Northwest Medical Plaza

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  • Freeman Health System

    Joplin, Missouri, 64804, United States

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220, United States

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864, United States

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409, United States

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    Creston, Iowa, 50801, United States

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601, United States

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269, United States

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310, United States

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    Poulsbo, Washington, 98370, United States

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    Saint Joseph, Missouri, 64506, United States

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    Kewanee, Illinois, 61443, United States

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    Ottawa, Illinois, 61350, United States

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    Des Moines, Iowa, 50316, United States

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    Des Moines, Iowa, 50309, United States

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    Louisville, Kentucky, 40202, United States

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    Shepherdsville, Kentucky, 40165, United States

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    Kennewick, Washington, 99336, United States

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    Anchorage, Alaska, 99508, United States

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    Kettering, Ohio, 45429, United States

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    Osage Beach, Missouri, 65065, United States

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    Vancouver, Washington, 98684, United States

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    Portland, Oregon, 97210, United States

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    Tualatin, Oregon, 97062, United States

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    Gresham, Oregon, 97030, United States

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    Basking Ridge, New Jersey, 07920, United States

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    Montvale, New Jersey, 07645, United States

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    New York, New York, 10065, United States

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    Commack, New York, 11725, United States

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    Middletown, New Jersey, 07748, United States

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    Uniondale, New York, 11553, United States

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    Geneva, Illinois, 60134, United States

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    Chicago, Illinois, 60611, United States

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    Peoria, Illinois, 61637, United States

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    Pekin, Illinois, 61554, United States

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    Peoria, Illinois, 61615, United States

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    Columbus, Ohio, 43210, United States

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    Cincinnati, Ohio, 45236, United States

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    Denver, Colorado, 80210, United States

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    Dayton, Ohio, 45409, United States

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    Clackamas, Oregon, 97015, United States

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    Newberg, Oregon, 97132, United States

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    Portland, Oregon, 97213, United States

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    Napa, California, 94558, United States

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    Everett, Washington, 98201, United States

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    Aberdeen, Washington, 98520, United States

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    Centralia, Washington, 98531, United States

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    Shelton, Washington, 98584, United States

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    Yelm, Washington, 98597, United States

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    Burbank, California, 91505, United States

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    Walla Walla, Washington, 99362, United States

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    Portland, Oregon, 97225, United States

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    Oregon City, Oregon, 97045, United States

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    Rego Park, New York, 11374, United States

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    Fort Myers, Florida, 33905, United States

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    Richmond, Indiana, 47374, United States

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    Somerville, New Jersey, 08876, United States

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    Longmont, Colorado, 80501, United States

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    Colorado Springs, Colorado, 80907, United States

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    Charleston, South Carolina, 29401, United States

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    Aurora, Illinois, 60504, United States

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    Yorkville, Illinois, 60560, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903, United States

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101, United States

  • SIH Cancer Institute

    Carterville, Illinois, 62918, United States

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228, United States

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401, United States

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    Alton, Illinois, 62002, United States

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    Livingston, New Jersey, 07039, United States

  • Saint Charles Health System

    Bend, Oregon, 97701, United States

  • Saint Charles Health System-Redmond

    Redmond, Oregon, 97756, United States

  • Saint Clare Hospital

    Lakewood, Washington, 98499, United States

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512, United States

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022, United States

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510, United States

  • Saint Elizabeth Youngstown Hospital

    Youngstown, Ohio, 44501, United States

  • Saint Francis Cancer Center

    Colorado Springs, Colorado, 80923, United States

  • Saint Francis Hospital

    Federal Way, Washington, 98003, United States

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703, United States

  • Saint Joseph Hospital

    Lexington, Kentucky, 40504, United States

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509, United States

  • Saint Joseph London

    London, Kentucky, 40741, United States

  • Saint Joseph Mount Sterling

    Mount Sterling, Kentucky, 40353, United States

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504, United States

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802, United States

  • Saint Joseph Warren Hospital

    Warren, Ohio, 44484, United States

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011, United States

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109, United States

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712, United States

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619, United States

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642, United States

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83686, United States

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301, United States

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004, United States

  • Saint Mary's Hospital

    Centralia, Illinois, 62801, United States

  • Saint Michael Cancer Center

    Silverdale, Washington, 98383, United States

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802, United States

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670, United States

  • Saints Mary and Elizabeth Hospital

    Louisville, Kentucky, 40215, United States

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501, United States

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122, United States

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104, United States

  • Sanford Cancer Center Worthington

    Worthington, Minnesota, 56187, United States

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601, United States

  • Sanford Medical Center Fargo

    Fargo, North Dakota, 58104, United States

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122, United States

  • Sanford South University Medical Center

    Fargo, North Dakota, 58103, United States

  • Sanford Thief River Falls Medical Center

    Thief River Falls, Minnesota, 56701, United States

  • Sanford USD Medical Center - Sioux Falls

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

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136, United States

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141, United States

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129, United States

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703, United States

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702, United States

  • Southpointe-Sanford Medical Center Fargo

    Fargo, North Dakota, 58103, United States

  • Southwest Oncology PC

    Durango, Colorado, 81301, United States

  • Springfield Clinic

    Springfield, Illinois, 62702, United States

  • Springfield Regional Cancer Center

    Springfield, Ohio, 45504, United States

  • Springfield Regional Medical Center

    Springfield, Ohio, 45504, United States

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304, United States

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794, United States

  • Summit Cancer Care-Memorial

    Savannah, Georgia, 31404, United States

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026, United States

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029, United States

  • Swedish Medical Center-Ballard Campus

    Seattle, Washington, 98107, United States

  • Swedish Medical Center-Cherry Hill

    Seattle, Washington, 98122-5711, United States

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122, United States

  • The Cancer Institute of New Jersey Hamilton

    Hamilton, New Jersey, 08690, United States

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Torrance Memorial Medical Center

    Torrance, California, 90509, United States

  • Torrance Memorial Physician Network - Cancer Care

    Torrance, California, 90505, United States

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255, United States

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247, United States

  • Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus

    Elizabeth, New Jersey, 07207, United States

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503, United States

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444, United States

  • Trinity Regional Medical Center

    Fort Dodge, Iowa, 50501, United States

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451, United States

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • UM Sylvester Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180, United States

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442, United States

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176, United States

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324, United States

  • UMass Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655, United States

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390, United States

  • United Hospital Center

    Bridgeport, West Virginia, 26330, United States

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817, 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 Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610, United States

  • University of Illinois

    Chicago, Illinois, 60612, United States

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136, United States

  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116, United States

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Michigan Health - West

    Wyoming, Michigan, 49519, United States

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106, United States

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920, United States

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792, United States

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245, United States

  • Upper Valley Medical Center

    Troy, Ohio, 45373, United States

  • Valley Radiation Oncology

    Peru, Illinois, 61354, United States

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204, United States

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Vanderbilt-Ingram Cancer Center Cool Springs

    Franklin, Tennessee, 37067, United States

  • Vanderbilt-Ingram Cancer Center at Franklin

    Franklin, Tennessee, 37067, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • WVUH-Berkely Medical Center

    Martinsburg, West Virginia, 25401, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Wayne Hospital

    Greenville, Ohio, 45331, United States

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007, United States

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506, United States

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401, United States

  • Woodland Memorial Hospital

    Woodland, California, 95695, United States

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