NCT02912559 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Atezolizumab: Given IV\> \> Biospecimen Collection: Undergo blood sample collection\> \> Computed Tomography: Undergo CT\> \> Fluorouracil: Given IV\> \> Leucovorin Calcium: Given IV\> \> Magnetic Resonance Imaging: Undergo MRI\> \> Oxaliplatin: Given IV\> \> Quality-of-Life Assessment: Ancillary studies
- id
- FG000
- title
- Arm I (Combination Chemotherapy, Atezolizumab)
- description
- Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Biospecimen Collection: Undergo blood sample collection\> \> Computed Tomography: Undergo CT\> \> Fluorouracil: Given IV\> \> Leucovorin Calcium: Given IV\> \> Magnetic Resonance Imaging: Undergo MRI\> \> Oxaliplatin: Given IV\> \> Quality-of-Life Assessment: Ancillary studies
- id
- FG001
- title
- Arm II (Combination Chemotherapy)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Disease progression prior to beginning treatment
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 25
- type
- Patient withdrawal prior to beginning treatment
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- type
- Unknown - prior to beginning treatment
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 13
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 62
- group Id
- FG001
- num Subjects
- 32
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- type
- Alternative therapy
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- type
- Complicating disease
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 2
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 76
- group Id
- FG001
- num Subjects
- 51
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 39
- group Id
- FG001
- num Subjects
- 14
- type
- Other
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 355
- group Id
- FG001
- num Subjects
- 357
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 163
- group Id
- FG001
- num Subjects
- 214
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 192
- group Id
- FG001
- num Subjects
- 143
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Atezolizumab: Given IV\> \> Biospecimen Collection: Undergo blood sample collection\> \> Computed Tomography: Undergo CT\> \> Fluorouracil: Given IV\> \> Leucovorin Calcium: Given IV\> \> Magnetic Resonance Imaging: Undergo MRI\> \> Oxaliplatin: Given IV\> \> Quality-of-Life Assessment: Ancillary studies
- id
- FG000
- title
- Arm I (Combination Chemotherapy, Atezolizumab)
- description
- Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Biospecimen Collection: Undergo blood sample collection\> \> Computed Tomography: Undergo CT\> \> Fluorouracil: Given IV\> \> Leucovorin Calcium: Given IV\> \> Magnetic Resonance Imaging: Undergo MRI\> \> Oxaliplatin: Given IV\> \> Quality-of-Life Assessment: Ancillary studies
- id
- FG001
- title
- Arm II (Combination Chemotherapy)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Disease progression prior to beginning treatment
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 25
- type
- Patient withdrawal prior to beginning treatment
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- type
- Unknown - prior to beginning treatment
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 13
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 62
- group Id
- FG001
- num Subjects
- 32
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- type
- Alternative therapy
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- type
- Complicating disease
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 2
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 76
- group Id
- FG001
- num Subjects
- 51
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 39
- group Id
- FG001
- num Subjects
- 14
- type
- Other
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 355
- group Id
- FG001
- num Subjects
- 357
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 163
- group Id
- FG001
- num Subjects
- 214
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 192
- group Id
- FG001
- num Subjects
- 143
- type
- NOT COMPLETED
- title
- Overall Study
Download exact source JSON → · Snapshot ctgov-results-aad7e863b8b06225cd4e94e7
Preserved source evidence · Not medical advice
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