NCT03228537 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- NEOADJUVANT: Patients receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity. SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo extrapleural pneumonectomy (EPP) or pleurectomy/decortication (PD). Patients who undergo EPP will then undergo radiation therapy. MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.
- id
- FG000
- title
- Treatment (Chemotherapy, Surgery +/- RT, Maintenance)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Progression/Relapse
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Death
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 28
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 21
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 7
- type
- NOT COMPLETED
- title
- Neoadjuvant
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Other - Not Protocol Specified
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 19
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 16
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 3
- type
- NOT COMPLETED
- title
- Surgery
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Refusal Unrelated to Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 10
- type
- Progression/Relapse
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 15
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 4
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- NOT COMPLETED
- title
- Maintenance
- pre Assignment Details
- 29 participants were registered to the study, 1 participant was ineligible, so 28 participants received protocol treatment for Step 1, Neoadjuvant.
Complete source fields
- groups
- description
- NEOADJUVANT: Patients receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity. SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo extrapleural pneumonectomy (EPP) or pleurectomy/decortication (PD). Patients who undergo EPP will then undergo radiation therapy. MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.
- id
- FG000
- title
- Treatment (Chemotherapy, Surgery +/- RT, Maintenance)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Progression/Relapse
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Death
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 28
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 21
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 7
- type
- NOT COMPLETED
- title
- Neoadjuvant
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Other - Not Protocol Specified
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 19
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 16
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 3
- type
- NOT COMPLETED
- title
- Surgery
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Refusal Unrelated to Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 10
- type
- Progression/Relapse
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 15
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 4
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- NOT COMPLETED
- title
- Maintenance
- pre Assignment Details
- 29 participants were registered to the study, 1 participant was ineligible, so 28 participants received protocol treatment for Step 1, Neoadjuvant.
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