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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
2012-12
NCT01099449Uploaded 10-18-2022
Access via NCI by Request
PDS UID: nci-data-497
A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neurotoxicity
Provider Information
Provider Data DescriptionDataset NCT01099449-D1-Dataset.csv (table1) is one of 7 datasets associated with PubMed ID 24297951. This dataset contains the information in table 1: Baseline Patient Characteristics.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Chemoprotective drugs, such as calcium gluconate and magnesium sulfate, may prevent neurotoxicity caused by oxaliplatin. It is not yet known which administration schedule of calcium gluconate and magnesium sulfate is more effective in preventing neurotoxicity. 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.
ConditionsChemotherapeutic Agent Toxicity
Colorectal Cancer
Neuropathy
Neurotoxicity
Intervention TypeDrug: calcium gluconate
Drug: magnesium sulfate
Other: placebo
Drug: oxaliplatin
Drug(s)Drug: calcium gluconate
Drug: magnesium sulfate
Drug: oxaliplatin
Total Enrolled362
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I - Experimental
Arm II - Placebo Comparator
Arm III - Experimental
Secondary IDNCCTG-N08CB
PubMed (PMID)34176021
24297951
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Puerto Rico
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01099449-D1
Data DictionaryNCT01099449-D1-Data-Dictionary_1.pdf
DATANCT01099449-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01099449-D2
Data DictionaryNCT01099449-D2-Data-Dictionary_2.pdf
DATANCT01099449-D2-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01099449-D3
Data DictionaryNCT01099449-D3-Data-Dictionary_1.pdf
DATANCT01099449-D3-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01099449-D4
Data DictionaryNCT01099449-D4-Data-Dictionary_1.pdf
DATANCT01099449-D4-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01099449-D5
Data DictionaryNCT01099449-D5-Data-Dictionary_1.pdf
DATANCT01099449-D5-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01099449-D6
Data DictionaryNCT01099449-D6-Data-Dictionary_1.pdf
DATANCT01099449-D6-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01099449-D7
Data DictionaryNCT01099449-D7-Data-Dictionary_1.pdf
DATANCT01099449-D7-Dataset_1.csv
OTHERREADME.pdf
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