RECRUITING

Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This trial studies how well iohexol works in helping doctors calculate the dose of carboplatin given to patients with cancer. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Understanding how to best calculate the dose of carboplatin given to patients with cancer may help doctors learn how to improve the use of carboplatin in the future.

Official Title

Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin

Quick Facts

Study Start:2020-01-15
Study Completion:2028-02-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03997370

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
  2. * For men who are sexually active, the need for use of medically acceptable contraception will be dictated by the primary treatment plan/protocol
  3. * Study accrual was closed to women on 08/18/2021 and accrual is now only open to males in order to meet accrual goals and study objectives. (11-AUG-2021)
  4. * Male sex
  5. * Any patients who will receive treatment with intravenous carboplatin (any AUC, any cycle) on a National Cancer Institute (NCI)-sponsored National Clinical Trial Network (NCTN)-, Experimental Therapeutics Clinical Trials Network (ETCTN)-, trial, local trial, or through standard of care
  6. * Age \>= 18
  7. * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  1. * Treated at an institute where creatinine is not measured with an IDMS calibrated assay
  2. * History of allergic reactions to computed tomography (CT) contrast, iodine or shellfish, or history of anaphylactic reaction to any food item
  3. * Recent (last 6 months) episode of acute kidney injury, have sickle cell disease, or have current indwelling nephrostomy tubes
  4. * Edema beyond trace edema, because this will impact iohexol equilibration and distribution
  5. * Ascites (including pleural effusion) beyond trace ascites, because this will impact iohexol equilibration and distribution
  6. * Whole- or part-limb amputees, because this will impact iohexol equilibration and distribution
  7. * Inability to maintain a constant dose and schedule of anti-inflammatory agents, diuretics, angiotensin II receptor blockers (ARB) and angiotensin converting enzyme inhibitors (ACEi) for one week prior to study visit, as this impacts renal function. If the patient is on a nonsteroidal anti-inflammatory drug (NSAID), diuretic, ARB or ACEi, they are eligible as long as these agents are taken on a set schedule for 7 or more days prior to study (and not on an "as needed" basis as that can cause fluctuations in renal function)
  8. * Inadequate venous access to obtain pharmacokinetic (PK) specimens
  9. * Multinodular goiter, Graves' disease or autoimmune thyroiditis, per iohexol package insert (hypothyroidism is allowed)

Contacts and Locations

Principal Investigator

Sarah E Taylor
PRINCIPAL_INVESTIGATOR
NRG Oncology

Study Locations (Sites)

University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, 85704
United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
United States
CARTI Cancer Center
Little Rock, Arkansas, 72205
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
UC San Diego Health System - Encinitas
Encinitas, California, 92024
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524
United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
United States
UCHealth Greeley Hospital
Greeley, Colorado, 80631
United States
Medical Center of the Rockies
Loveland, Colorado, 80538
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
United States
Sibley Memorial Hospital
Washington, District of Columbia, 20016
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
United States
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642
United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
United States
Saint Anthony's Health
Alton, Illinois, 62002
United States
Saint Mary's Hospital
Centralia, Illinois, 62801
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
The Carle Foundation Hospital
Urbana, Illinois, 61801
United States
Reid Health
Richmond, Indiana, 47374
United States
Mission Cancer and Blood - Ankeny
Ankeny, Iowa, 50023
United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
Mission Cancer and Blood - Des Moines
Des Moines, Iowa, 50309
United States
Broadlawns Medical Center
Des Moines, Iowa, 50314
United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
United States
Trinity Regional Medical Center
Fort Dodge, Iowa, 50501
United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700
United States
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
United States
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, 41017
United States
Hematology/Oncology Clinic PLLC
Baton Rouge, Louisiana, 70809
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
United States
Cox Cancer Center Branson
Branson, Missouri, 65616
United States
Freeman Health System
Joplin, Missouri, 64804
United States
Mercy Hospital Joplin
Joplin, Missouri, 64804
United States
Lake Regional Hospital
Osage Beach, Missouri, 65065
United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401
United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
United States
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, 63109
United States
Mercy Hospital South
Saint Louis, Missouri, 63128
United States
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
United States
Mercy Hospital Springfield
Springfield, Missouri, 65804
United States
CoxHealth South Hospital
Springfield, Missouri, 65807
United States
Mercy Hospital Washington
Washington, Missouri, 63090
United States
Community Hospital of Anaconda
Anaconda, Montana, 59711
United States
Billings Clinic Cancer Center
Billings, Montana, 59101
United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
United States
Great Falls Clinic
Great Falls, Montana, 59405
United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901
United States
Community Medical Center
Missoula, Montana, 59804
United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080
United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876
United States
Montefiore Medical Center-Einstein Campus
Bronx, New York, 10461
United States
Montefiore Medical Center-Weiler Hospital
Bronx, New York, 10461
United States
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Memorial Sloan Kettering Commack
Commack, New York, 11725
United States
The Cancer Institute at Saint Francis Hospital
East Hills, New York, 11548
United States
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, 14905
United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Highland Hospital
Rochester, New York, 14620
United States
University of Rochester
Rochester, New York, 14642
United States
State University of New York Upstate Medical University
Syracuse, New York, 13210
United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
United States
Good Samaritan University Hospital
West Islip, New York, 11795
United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
United States
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
United States
Miami Valley Hospital South
Centerville, Ohio, 45459
United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Miami Valley Hospital
Dayton, Ohio, 45409
United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
United States
Miami Valley Hospital North
Dayton, Ohio, 45415
United States
Armes Family Cancer Center
Findlay, Ohio, 45840
United States
Blanchard Valley Hospital
Findlay, Ohio, 45840
United States
Orion Cancer Care
Findlay, Ohio, 45840
United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
United States
Wayne Hospital
Greenville, Ohio, 45331
United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409
United States
First Dayton Cancer Care
Kettering, Ohio, 45420
United States
Kettering Medical Center
Kettering, Ohio, 45429
United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124
United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504
United States
Springfield Regional Medical Center
Springfield, Ohio, 45504
United States
Dayton Physicians LLC - Troy
Troy, Ohio, 45373
United States
Upper Valley Medical Center
Troy, Ohio, 45373
United States
Saint Joseph Warren Hospital
Warren, Ohio, 44484
United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
United States
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814
United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
United States
Women and Infants Hospital
Providence, Rhode Island, 02905
United States
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
United States
Vanderbilt-Ingram Cancer Center at Franklin
Franklin, Tennessee, 37067
United States
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee, 37067
United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, 37204
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
United States
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, 84106
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
United States
Monongalia Hospital
Morgantown, West Virginia, 26505
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Billings Clinic-Cody
Cody, Wyoming, 82414
United States
Welch Cancer Center
Sheridan, Wyoming, 82801
United States

Collaborators and Investigators

Sponsor: NRG Oncology

  • Sarah E Taylor, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-15
Study Completion Date2028-02-06

Study Record Updates

Study Start Date2020-01-15
Study Completion Date2028-02-06

Terms related to this study

Additional Relevant MeSH Terms

  • Malignant Solid Neoplasm