NCT00686959 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 milligrams per meter squared (mg/m\^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray \[Gy\] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
- id
- FG000
- title
- Arm A: Pemetrexed + Cisplatin and TRT
- description
- Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
- id
- FG001
- title
- Arm B: Etoposide + Cisplatin and TRT
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 124
- group Id
- FG001
- num Subjects
- 117
- type
- Participants censored (no death events)
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 301
- group Id
- FG001
- num Subjects
- 297
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 283
- group Id
- FG001
- num Subjects
- 272
- type
- Received at Least One Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 229
- group Id
- FG001
- num Subjects
- 202
- type
- Entered Consolidation Phase
- achievements
- comment
- Study completion includes death due to any cause
- group Id
- FG000
- num Subjects
- 177
- comment
- Study completion includes death due to any cause.
- group Id
- FG001
- num Subjects
- 180
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 124
- group Id
- FG001
- num Subjects
- 117
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 milligrams per meter squared (mg/m\^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray \[Gy\] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
- id
- FG000
- title
- Arm A: Pemetrexed + Cisplatin and TRT
- description
- Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
- id
- FG001
- title
- Arm B: Etoposide + Cisplatin and TRT
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 124
- group Id
- FG001
- num Subjects
- 117
- type
- Participants censored (no death events)
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 301
- group Id
- FG001
- num Subjects
- 297
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 283
- group Id
- FG001
- num Subjects
- 272
- type
- Received at Least One Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 229
- group Id
- FG001
- num Subjects
- 202
- type
- Entered Consolidation Phase
- achievements
- comment
- Study completion includes death due to any cause
- group Id
- FG000
- num Subjects
- 177
- comment
- Study completion includes death due to any cause.
- group Id
- FG001
- num Subjects
- 180
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 124
- group Id
- FG001
- num Subjects
- 117
- type
- NOT COMPLETED
- title
- Overall Study
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