Clinical TrialID 5623
First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib
NCT01289821
Colorectal Neoplasms
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5623
- Evidence Id
- 5623
- Core Evidence Id
- 5623
- Source Clinical Trial Id
- 5604
- Herb2 Clinical Trial Id
- HBCT005604
- Nct Id
- NCT01289821
- Title
- First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib
- Status
- Completed
- Phase
- Phase 2
- Study Result
- Yes
- Study Condition
- Colorectal Neoplasms
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Regorafenib (Stivarga, BAY73-4506)|DRUG: Oxaliplatin|DRUG: Folinic acid|DRUG: 5-FU (mFOLFOX6)
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 54
- Outcome Measure
- Objective Response (OR), OR was defined as the best tumor response (confirmed complete response \[CR\] or partial response \[PR\]) observed by MRI or CT scan assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). Any pathological lymph nodes (whether target or non target) must have a reduction in short axis to \< 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing nontarget lesions and no appearance of new lesions., From start of treatment until 30 days after termination of study medication, an average of 47 weeks. Assessed every 8 weeks.
- Sponsor Collaborator
- Bayer
- Funded By
- INDUSTRY
- Location
- Chicago, Illinois, 60611-2906, United States|Concord, New South Wales, 2139, Australia|Woodville South, South Australia, 5011, Australia|Bruxelles - Brussel, 1070, Belgium|Edegem, 2650, Belgium|Leuven, 3000, Belgium|Stuttgart, Baden-Württemberg, 70199, Germany|Oldenburg, Niedersachsen, 26133, Germany|Herne, Nordrhein-Westfalen, 44625, Germany|Dresden, Sachsen, 01307, Germany|Napoli, Campania, 80131, Italy|Genova, Liguria, 16132, Italy|Ancona, Marche, 60126, Italy|Santander, Cantabria, 39008, Spain|Barcelona, 08035, Spain|Madrid, 28034, Spain|Glasgow, G12 0YN, United Kingdom|Manchester, M20 4BX, United Kingdom
- Other Id
- 11728|2010-020121-41
- Start Date
- 2011-02
- Primary Completion Date
- 2012-03
- Completion Date
- 2014-06
- First Posted
- 2011-02-04
- Results First Posted
- 2013-09-04
- Last Update Posted
- 2017-03-15
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01289821
- Title Cn
- Title En
- First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib
- Bilingual Status
- semi_complete