TriangleNCT02372409 · OUTCOME
Arm A Only: Number of Participants With Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 5 years from date of registration (median length of follow-up, full range 196 days-1801 days)
What was measured
PFS is followed from start of treatment to time of progression or death, whichever occurs first.
Analysis population: This outcome measure is for Arm A participants only.
Groups in this outcome
Arm A (MRI-guided Laser Ablation)
* MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * Every 12 weeks (+/- 7 days) for the first year or until disease progression
Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
* MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Within 7 days of MLA (range 2-14 days) doxorubicin will be given intravenously on an outpatient basis weekly for 6 weeks at a dose of 25 mg/m\^2 over 5-30 minutes * Following the completion of doxorubin, etoposide 50 mg/m\^2/day will be given orally for 21 days of each 28-day cycle (treatment can continue up to 24 cycles) * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * every 8 weeks (+/- 7 days) until 2 years have elapsed or disease progression, whichever comes first
| Group | Source count |
|---|---|
| Arm A (MRI-guided Laser Ablation) | 5 |
| Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide) | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (MRI-guided Laser Ablation) | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- PFS is followed from start of treatment to time of progression or death, whichever occurs first.
- groups
- description
- * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * Every 12 weeks (+/- 7 days) for the first year or until disease progression
- id
- OG000
- title
- Arm A (MRI-guided Laser Ablation)
- description
- * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Within 7 days of MLA (range 2-14 days) doxorubicin will be given intravenously on an outpatient basis weekly for 6 weeks at a dose of 25 mg/m\^2 over 5-30 minutes * Following the completion of doxorubin, etoposide 50 mg/m\^2/day will be given orally for 21 days of each 28-day cycle (treatment can continue up to 24 cycles) * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * every 8 weeks (+/- 7 days) until 2 years have elapsed or disease progression, whichever comes first
- id
- OG001
- title
- Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- This outcome measure is for Arm A participants only.
- reporting Status
- POSTED
- time Frame
- Up to 5 years from date of registration (median length of follow-up, full range 196 days-1801 days)
- title
- Arm A Only: Number of Participants With Progression-free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice