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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
April 2015
NCT00303628Uploaded 05-04-2021
Access via NCI by Request
PDS UID: nci-data-467
Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients With Stage II or III Rectal Cancer Receiving Pre-operative Chemoradiation
Provider Information
Provider Data DescriptionThere are five different submissions for PMID 31852811 from trial E5204. This dataset, NCT00303628-D1, contains baseline, treatment, and efficacy data. Dataset NCT00303628-D2 contains toxicity data. Dataset NCT00303628-D3 contains PRO Bowel function/uniscale data. Dataset NCT00303628-D4 contains PRO FACT-Diarrhea Data. Dataset NCT00303628-D5 contains PRO FACT/GOG-Ntx Data.
SponsorECOG-ACRIN Cancer Research Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryDrugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating rectal cancer. This randomized phase III trial is studying combination chemotherapy to see how well it works with or without bevacizumab in treating patients who have had surgery for stage II or stage III rectal cancer.
ConditionsAdenocarcinoma of the Rectum
Stage II Rectal Cancer
Stage III Rectal Cancer
Intervention TypeDrug: oxaliplatin
Drug: fluorouracil
Drug: leucovorin calcium
Drug: bevacizumab
Drug(s)Drug: oxaliplatin
Drug: fluorouracil
Drug: leucovorin calcium
Drug: bevacizumab
Total Enrolled355
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - Active Comparator
Arm II - Experimental
Secondary IDNCI-2009-00563
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Peru
Puerto Rico
Age Range18 Years and older (Adult, Older Adult)
Files: NCT00303628-D1
Data DictionaryNCT00303628-D1-Data-Dictionary_1.pdf
DATANCT00303628-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00303628-D2
Data DictionaryNCT00303628-D2-Data-Dictionary_1.pdf
DATANCT00303628-D2-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00303628-D3
Data DictionaryNCT00303628-D3-Data-Dictionary_1.pdf
DATANCT00303628-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT00303628-D4
Data DictionaryNCT00303628-D4-Data-Dictionary_1.pdf
DATANCT00303628-D4-Dataset.csv
OTHERREADME.pdf
Files: NCT00303628-D5
Data DictionaryNCT00303628-D5-Data-Dictionary_2.pdf
DATANCT00303628-D5-Dataset.csv
OTHERREADME.pdf
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