Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy
NCT ID: NCT01099449
Last Updated: 2022-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
362 participants
INTERVENTIONAL
2010-06-30
2013-03-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying different administration schedules of calcium gluconate and magnesium sulfate and comparing how well they work in neurotoxicity in patients with colon cancer or rectal cancer receiving oxaliplatin-based combination chemotherapy.
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Detailed Description
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Primary
* To determine whether 2 schedules of calcium gluconate and magnesium sulfate infusions (given before and after chemotherapy or just before chemotherapy) can prevent or ameliorate chronic, cumulative oxaliplatin-induced sensory neurotoxicity in patients with colon or rectal cancer receiving adjuvant FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin.
Secondary
* To determine whether these 2 infusion schedules can increase the cumulative oxaliplatin doses that can be delivered without dose-limiting chronic neurotoxicity.
* To determine whether these 2 infusion schedules can ameliorate acute neuropathy associated with oxaliplatin.
* To determine whether these 2 infusion schedules cause adverse events.
* To investigate whether these 2 infusions schedules influence patient quality of life.
* To describe baseline and post-treatment neurological quantitative sensory testing abnormalities in the study participants.
Tertiary
* To explore if polymorphisms in the GSTP1, GSTM1, ERCC2, and XRCC1 genes are associated with early onset of oxaliplatin-induced neurotoxicity.
OUTLINE: This is a multicenter study. Patients are stratified according to age (\< 65 years vs ≥ 65 years), gender, regimen (FOLFOX4 vs modified FOLFOX6 vs other), and stage of disease (II vs III vs IV). Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive calcium gluconate IV and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).
* Arm II: Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).
* Arm III: Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).
In all arms, courses repeat every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.
Blood samples are collected before the second course of treatment for translational research.
Patients complete questionnaires on side effects, quality of life, and chemotherapy-induced peripheral neuropathy periodically.
After completion of study treatment, patients are followed up at 3, 6, 12, and 18 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Arm I
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).
calcium gluconate
Given IV
magnesium sulfate
Given IV
oxaliplatin
Arm II
Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).
placebo
Given IV
oxaliplatin
Arm III
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).
calcium gluconate
Given IV
magnesium sulfate
Given IV
placebo
Given IV
oxaliplatin
Interventions
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calcium gluconate
Given IV
magnesium sulfate
Given IV
placebo
Given IV
oxaliplatin
Eligibility Criteria
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Inclusion Criteria
* ECOG performance status 0-2
* WBC ≥ 3,000/mm\^3
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10.0 g/dL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Serum creatinine ≤ 1.5 times ULN
* Serum calcium ≤ 1.2 times ULN
* Serum magnesium ≤ 1.2 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to complete questionnaires (alone or with assistance)
* Able to comply with study treatment
* Willing to return to enrolling institution for follow-up
* Willing to provide blood sample for research purposes
* No pre-existing peripheral neuropathy of any grade
* No family history of a genetic/familial neuropathy
* No second or third degree AV heart block or a history of second or third degree heart block
* Bundle branch blocks are allowed.
* No other medical conditions that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Central venous access line present, or scheduled to have a central line placed before starting chemotherapy and study treatment
* No prior treatment with neurotoxic chemotherapy (e.g., oxaliplatin, cisplatin, taxanes, or vinca alkaloids)
* No concurrent digitalis medication
* No concurrent treatment with the anticonvulsants carbamazepine (e.g., Tegretol®), phenytoin (e.g., Dilantin®), valproic acid (e.g., Depakene®), gabapentin (Neurontin®), or pregabalin (Lyrica®)
* No concurrent neurotropic agents, including venlafaxine (Effexor), desvenlafaxine (Pristiq®), milnacipran (Savella®), or duloxetine (Cymbalta)
* No concurrent tricyclic antidepressants (such as amitryptilline), or any other agent specifically being given to prevent or treat neuropathy
* No concurrent drugs given as a neuroprotectant
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Charles L. Loprinzi, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
Kaiser Permanente - Deer Valley
Antioch, California, United States
North Bay Cancer Center
Fairfield, California, United States
Kaiser Permanente - Fremont
Fremont, California, United States
Kaiser Permanente Fresno Medical Center
Fresno, California, United States
Kaiser Permanente Medical Center - Hayward
Hayward, California, United States
Kaiser Permanente Medical Center - Oakland
Oakland, California, United States
Pismo Beach, California, United States
Kaiser Permanente Medical Center - Redwood City
Redwood City, California, United States
Kaiser Permanente Medical Center - Richmond
Richmond, California, United States
Kaiser Permanente Medical Center - Roseville
Roseville, California, United States
South Sacramento Kaiser-Permanente Medical Center
Sacramento, California, United States
Kaiser Permanente Medical Center - Sacramento
Sacramento, California, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, United States
Kaiser Permanente Medical Center - Santa Teresa
San Jose, California, United States
Kaiser Foundation Hospital - San Rafael
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa, California, United States
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California, United States
Kaiser Permanente Medical Facility - Stockton
Stockton, California, United States
Kaiser Permanente Medical Center - Vacaville
Vacaville, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
Kaiser Permanente Medical Center - Walnut Creek
Walnut Creek, California, United States
Aurora Presbyterian Hospital
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States
St. Anthony Central Hospital
Denver, Colorado, United States
Kaiser Permanente - Denver
Denver, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States
St. Joseph Hospital
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
Kaiser Permanente - Lafayette
Lafayette, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States
North Suburban Medical Center
Thornton, Colorado, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
North Broward Medical Center
Deerfield Beach, Florida, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
Albany, Georgia, United States
Piedmont Hospital
Atlanta, Georgia, United States
Northside Hospital Cancer Center
Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
WellStar Cobb Hospital
Austell, Georgia, United States
John B. Amos Cancer Center
Columbus, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, United States
Gwinnett Medical Center
Lawrenceville, Georgia, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, United States
Southern Regional Medical Center
Riverdale, Georgia, United States
Harbin Clinic Cancer Center - Medical Oncology
Rome, Georgia, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, United States
Hawaii Medical Center - East
Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, United States
Kaiser Permanente - Moanalua Medical Center and Clinic
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Maui Memorial Medical Center
Wailuku, Hawaii, United States
Pacific Cancer Institute - Maui
Wailuku, Hawaii, United States
Kapiolani Medical Center at Pali Momi
‘Aiea, Hawaii, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
St. Joseph Regional Medical Center
Lewiston, Idaho, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Illinois CancerCare - Canton
Canton, Illinois, United States
Illinois CancerCare - Carthage
Carthage, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Illinois CancerCare - Eureka
Eureka, Illinois, United States
Galesburg Clinic, PC
Galesburg, Illinois, United States
Illinois CancerCare - Galesburg
Galesburg, Illinois, United States
Illinois CancerCare - Havana
Havana, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, United States
Illinois CancerCare - Macomb
Macomb, Illinois, United States
McDonough District Hospital
Macomb, Illinois, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, United States
Moline, Illinois, United States
Illinois CancerCare - Monmouth
Monmouth, Illinois, United States
BroMenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center
Normal, Illinois, United States
Illinois CancerCare - Community Cancer Center
Normal, Illinois, United States
Community Hospital of Ottawa
Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Illinois CancerCare - Pekin
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Illinois CancerCare - Peru
Peru, Illinois, United States
Illinois Valley Community Hospital
Peru, Illinois, United States
Illinois CancerCare - Princeton
Princeton, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
West Suburban Center for Cancer Care
River Forest, Illinois, United States
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States
Elkhart Clinic, LLC
Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Clarian Arnett Cancer Care
Lafayette, Indiana, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States
Reid Hospital & Health Care Services
Richmond, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States
Bettendorf, Iowa, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, United States
Mercy Cancer Center - West Lakes
Clive, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Covenant Cancer Treatment Center
Waterloo, Iowa, United States
Methodist West Hospital
West Des Moines, Iowa, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
Saint Luke's Hospital - South
Overland Park, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
CCOP - Kansas City
Prairie Village, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States
York Hospital's Oncology Treatment Center
York Village, Maine, United States
Shore Regional Cancer Center at Memorial Hospital - Easton
Easton, Maryland, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
Sturdy Memorial Hospital
Attleboro, Massachusetts, United States
Boston University Cancer Research Center
Boston, Massachusetts, United States
Caritas St. Elizabeth's Medical Center
Brighton, Massachusetts, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, United States
Foote Memorial Hospital
Jackson, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Sparrow Regional Cancer Center
Lansing, Michigan, United States
St. Mary Mercy Hospital
Livonia, Michigan, United States
Community Cancer Center of Monroe
Monroe, Michigan, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States
Michiana Hematology Oncology PC - Niles
Niles, Michigan, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, United States
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States
CCOP - Duluth
Duluth, Minnesota, United States
Miller - Dwan Medical Center
Duluth, Minnesota, United States
Immanuel St. Joseph's
Mankato, Minnesota, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Saint Luke's Hospital
Chesterfield, Missouri, United States
Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States
North Kansas City Hospital
Kansas City, Missouri, United States
Parvin Radiation Oncology
Kansas City, Missouri, United States
Heartland Hematology Oncology Associates, Incorporated
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Saint Joseph Oncology, Incorporated
Saint Joseph, Missouri, United States
Saint Louis University Cancer Center
St Louis, Missouri, United States
St. Anthony's Cancer Center
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
Comprehensive Cancer Care, PC
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Billings Clinic - Downtown
Billings, Montana, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States
St. James Healthcare Cancer Care
Butte, Montana, United States
Big Sky Oncology
Great Falls, Montana, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
Northern Montana Hospital
Havre, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Immanuel Medical Center
Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, United States
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States
Lakes Region General Hospital
Laconia, New Hampshire, United States
Oncology Center at St. Joseph Hospital
Nashua, New Hampshire, United States
Trinitas Comprehensive Cancer Center at Trinitas Hospital
Elizabeth, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Kings County Hospital Center
Brooklyn, New York, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
Cooperstown, New York, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States
Monter Cancer Center of the North Shore-LIJ Health System
Lake Success, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States
Randolph Hospital
Asheboro, North Carolina, United States
CaroMont Cancer Center at Gaston Memorial Hospital
Gastonia, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States
Pardee Memorial Hospital
Hendersonville, North Carolina, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States
Annie Penn Cancer Center
Reidsville, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Bismarck Cancer Center
Bismarck, North Dakota, United States
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States
Trinity CancerCare Center
Minot, North Dakota, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Wood County Oncology Center
Bowling Green, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital
Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Cancer Care Center
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Community Cancer Center
Elyria, Ohio, United States
Hematology Oncology Center
Elyria, Ohio, United States
Blanchard Valley Medical Associates
Findlay, Ohio, United States
Middletown Regional Hospital
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
St. Rita's Medical Center
Lima, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Northwest Ohio Oncology Center
Maumee, Ohio, United States
St. Charles Mercy Hospital
Oregon, Ohio, United States
Toledo Clinic - Oregon
Oregon, Ohio, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States
Flower Hospital Cancer Center
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
St. Anne Mercy Hospital
Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Air Force Base, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
LaFortune Cancer Center at St. John Medical Center
Tulsa, Oklahoma, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States
Kaiser Permanente Health Care - Portland
Portland, Oregon, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
Kent County Memorial Hospital
Warwick, Rhode Island, United States
AnMed Cancer Center
Anderson, South Carolina, United States
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, United States
Cancer Centers of the Carolinas - Easley
Easley, South Carolina, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Bon Secours St. Francis Health System
Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Grove Commons
Greenville, South Carolina, United States
Greenville Hospital Cancer Center
Greenville, South Carolina, United States
Self Regional Cancer Center at Self Regional Medical Center
Greenwood, South Carolina, United States
Cancer Centers of the Carolinas - Greer Medical Oncology
Greer, South Carolina, United States
Carolina Blood and Cancer Care Associates, PA
Lancaster, South Carolina, United States
Carolina Blood and Cancer Care
Rock Hill, South Carolina, United States
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States
Hematology-Oncology Associates of Fredericksburg, Incorporated
Fredericksburg, Virginia, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
Martinsville, Virginia, United States
Southwest Virginia Regional Cancer Center at Wellmonth Health
Norton, Virginia, United States
Overlake Cancer Center at Overlake Hospital Medical Center
Bellevue, Washington, United States
St. Joseph Cancer Center
Bellingham, Washington, United States
Providence Centralia Hospital
Centralia, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
St. Francis Hospital
Federal Way, Washington, United States
Cascade Cancer Center at Evergreen Hospital Medical Center
Kirkland, Washington, United States
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States
Good Samaritan Cancer Center
Puyallup, Washington, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Pacific Medical Center
Seattle, Washington, United States
Franciscan Cancer Center at St. Joseph Medical Center
Tacoma, Washington, United States
Allenmore Hospital
Tacoma, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States
St. Clare Hospital
Tacoma, Washington, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center
Huntington, West Virginia, United States
Langlade Memorial Hospital
Antigo, Wisconsin, United States
Fox Valley Hematology and Oncology - East Grant Street
Appleton, Wisconsin, United States
Marshfield Clinic - Chippewa Center
Chippewa Falls, Wisconsin, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States
Central Wisconsin Cancer Program at Agnesian HealthCare
Fond du Lac, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Mercy Regional Cancer Center
Janesville, Wisconsin, United States
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States
St. Nicholas Hospital
Sheboygan, Wisconsin, United States
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Oncology Alliance, SC - Milwaukee - West
Wauwatosa, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Riverview UW Cancer Center at Riverview Hospital
Wisconsin Rapids, Wisconsin, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States
San Juan City Hospital
San Juan, , Puerto Rico
Countries
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References
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Hertz DL, Dockter TJ, Satele DV, Loprinzi CL, Le-Rademacher J. Neuropathy severity at the time of oxaliplatin treatment alteration in patients with colon cancer (Alliance A151912). Support Care Cancer. 2021 Dec;29(12):7855-7863. doi: 10.1007/s00520-021-06371-x. Epub 2021 Jun 27.
Loprinzi CL, Qin R, Dakhil SR, Fehrenbacher L, Flynn KA, Atherton P, Seisler D, Qamar R, Lewis GC, Grothey A. Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance). J Clin Oncol. 2014 Apr 1;32(10):997-1005. doi: 10.1200/JCO.2013.52.0536. Epub 2013 Dec 2.
Related Links
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Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
Other Identifiers
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NCCTG-N08CB
Identifier Type: -
Identifier Source: secondary_id
CDR0000669660
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2011-02036
Identifier Type: REGISTRY
Identifier Source: secondary_id
N08CB
Identifier Type: -
Identifier Source: org_study_id
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