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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
August 2013
NCT00058474Uploaded 03-02-2021
Access via NCI by Request
PDS UID: nci-data-457
A Clinical Trial Comparing Preoperative Radiation Therapy And Capecitabine With or Without Oxaliplatin With Preoperative Radiation Therapy And Continuous Intravenous Infusion Of 5-Fluorouracil With or Without Oxaliplatin In The Treatment Of Patients With Operable Carcinoma Of The Rectum
Provider Information
Provider Data DescriptionThe file NCT00058474-D1-Dataset.csv contains all data necessary to produce the results reported in the above manuscript.
SponsorNSABP Foundation Inc
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as capecitabine, fluorouracil, and oxaliplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: This randomized phase III trial is studying radiation therapy and either capecitabine or fluorouracil with or without oxaliplatin and comparing them to see how well they work when given before surgery in treating patients with resectable rectal cancer. It is not yet known whether radiation therapy and either capecitabine or fluorouracil is more effective with or without oxaliplatin in treating rectal cancer.
ConditionsColorectal Cancer
Intervention TypeDrug: capecitabine
Drug: fluorouracil
Drug: oxaliplatin
Radiation: radiation therapy
Drug(s)Drug: fluorouracil
Drug: oxaliplatin
Drug: capecitabine
Total Enrolled1608
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm 1: 5-FU + RT - Active Comparator
Arm 2: 5-FU + RT + Oxaliplatin - Experimental
Arm 3: Capecitabine + RT - Experimental
Arm 4: Capecitabine + RT + Oxaliplatin - Experimental
Secondary IDNSABP-R-04
PubMed (PMID)24799484
24670844
35749631
Collaborator(s)National Cancer Institute (NCI)
Cancer and Leukemia Group B
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Files: NCT00058474-D1
Data DictionaryNCT00058474-D1-Data-Dictionary_3.pdf
DATANCT00058474-D1-Dataset_1.csv
OTHERREADME.pdf
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