TriangleNCT02065687 · OUTCOME
Proportion of Patients Responding to Therapy
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- During study treatment, up to 5 years.
What was measured
The proportion of patients who had a response (complete or partial) by RECIST 1.1. Measurable disease is defined by RECIST (version 1.1). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray. Lymph nodes must be \> 15 mm in short axis when measured by CT or MRI.
Analysis population: Evaluable for response
Groups in this outcome
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)
Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II (Paclitaxel, Carboplatin, Placebo)
Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 164 |
| Arm II (Paclitaxel, Carboplatin, Placebo) | 171 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 61.6 | Not reported | 53.7 | 69.1 | Not reported |
| Arm II (Paclitaxel, Carboplatin, Placebo) | 60.2 | Not reported | 52.5 | 67.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 53.7
- upper Limit
- 69.1
- value
- 61.6
- group Id
- OG001
- lower Limit
- 52.5
- upper Limit
- 67.6
- value
- 60.2
- denoms
- counts
- group Id
- OG000
- value
- 164
- group Id
- OG001
- value
- 171
- units
- Participants
- description
- The proportion of patients who had a response (complete or partial) by RECIST 1.1. Measurable disease is defined by RECIST (version 1.1). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray. Lymph nodes must be \> 15 mm in short axis when measured by CT or MRI.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)
- description
- Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm II (Paclitaxel, Carboplatin, Placebo)
- param Type
- NUMBER
- population Description
- Evaluable for response
- reporting Status
- POSTED
- time Frame
- During study treatment, up to 5 years.
- title
- Proportion of Patients Responding to Therapy
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice