TriangleNCT00686959 · OUTCOME
Objective Response Rate (Complete Response [CR] + Partial Response [PR])
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline to Measured Progressive Disease (Up to 7 Months)
What was measured
Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Analysis population: All randomized participants.
Groups in this outcome
Arm A: Pemetrexed + Cisplatin and TRT
Participants were treated with Pemetrexed plus Cisplatin and concurrent 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 mg/m\^2, 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 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
Arm B: Etoposide + Cisplatin and TRT
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
| Group | Source count |
|---|---|
| Arm A: Pemetrexed + Cisplatin and TRT | 301 |
| Arm B: Etoposide + Cisplatin and TRT | 297 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Pemetrexed + Cisplatin and TRT | 35.9 | Not reported | 30.46 | 41.58 | Not reported |
| Arm B: Etoposide + Cisplatin and TRT | 33.0 | Not reported | 27.67 | 38.66 | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.458
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.458
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30.46
- upper Limit
- 41.58
- value
- 35.9
- group Id
- OG001
- lower Limit
- 27.67
- upper Limit
- 38.66
- value
- 33.0
- denoms
- counts
- group Id
- OG000
- value
- 301
- group Id
- OG001
- value
- 297
- units
- Participants
- description
- Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were treated with Pemetrexed plus Cisplatin and concurrent 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 mg/m\^2, 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 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
- OG000
- 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
- OG001
- title
- Arm B: Etoposide + Cisplatin and TRT
- param Type
- NUMBER
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- Baseline to Measured Progressive Disease (Up to 7 Months)
- title
- Objective Response Rate (Complete Response [CR] + Partial Response [PR])
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice