TriangleNCT02584309 · OUTCOME
Progression-free Survival (PFS) (Arm 1 Only)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 5 years
What was measured
* PFS is defined as the time from on study to the first occurrence of progression or death, whichever occurs first. * If no event exists, the PFS will be censored at the last follow-up. * Progressive disease - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Analysis population: Participants enrolled in Arm 2 are not evaluable for this outcome measure.
Groups in this outcome
Arm 1: Doxorubicin and Upfront Dexrazoxane
* Dexrazoxane will be given intravenously on an outpatient basis over 15 minutes on each day that doxorubicin is given. * Dexrazoxane should be given no more than 30 minutes prior to administration of doxorubicin, which is typically given on Day 1 of a 21-day cycle. * Dosing is a 10:1 ratio of dexrazoxane to doxorubicin; doxorubicin is typically given at 75 mg/m2, so dexrazoxane dosing would be 750 mg/m2. * In the event of a national shortage of dexrazoxane, 72-hour infusional doxorubicin can be used instead of dexrazoxane and bolus doxorubicin..
Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)
* Doxorubicin is given as standard of care. Doxorubicin is typically given at 75 mg/m2 on Day 1 of a 21-day cycle. * Starting with cycle 5, standard of care dexrazoxane (75 mg/m2) will be given for 4 cycles. * The last 10 patients enrolled after completion of enrollment to Arm 1 will be enrolled to Arm 2.
| Group | Source count |
|---|---|
| Arm 1: Doxorubicin and Upfront Dexrazoxane | 62 |
| Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Doxorubicin and Upfront Dexrazoxane | 5.48 | Not reported | 4.01 | 7.37 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.01
- upper Limit
- 7.37
- value
- 5.48
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- * PFS is defined as the time from on study to the first occurrence of progression or death, whichever occurs first. * If no event exists, the PFS will be censored at the last follow-up. * Progressive disease - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- * Dexrazoxane will be given intravenously on an outpatient basis over 15 minutes on each day that doxorubicin is given. * Dexrazoxane should be given no more than 30 minutes prior to administration of doxorubicin, which is typically given on Day 1 of a 21-day cycle. * Dosing is a 10:1 ratio of dexrazoxane to doxorubicin; doxorubicin is typically given at 75 mg/m2, so dexrazoxane dosing would be 750 mg/m2. * In the event of a national shortage of dexrazoxane, 72-hour infusional doxorubicin can be used instead of dexrazoxane and bolus doxorubicin..
- id
- OG000
- title
- Arm 1: Doxorubicin and Upfront Dexrazoxane
- description
- * Doxorubicin is given as standard of care. Doxorubicin is typically given at 75 mg/m2 on Day 1 of a 21-day cycle. * Starting with cycle 5, standard of care dexrazoxane (75 mg/m2) will be given for 4 cycles. * The last 10 patients enrolled after completion of enrollment to Arm 1 will be enrolled to Arm 2.
- id
- OG001
- title
- Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)
- param Type
- MEDIAN
- population Description
- Participants enrolled in Arm 2 are not evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Progression-free Survival (PFS) (Arm 1 Only)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice