TriangleNCT01730937 · OUTCOME
Progression-free Survival
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
- From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.
What was measured
Failure for progression-free survival (PFS) include death, new tumor thrombosis, progression of hepatocellular carcinoma (HCC) within liver excluding tumor thrombosis status, progression of distant Mets that were present at study entry, new HCC within liver including tumor thrombosis, and vascular thrombosis events =progression-new enhancing tumor thrombosis/progression-Increase in the volume of enhancing portion of thrombosis. PFS time is defined as the time from randomization to the date of first failure, date of death, or last known follow-up (censored). PFS rates are estimated by the Kaplan-Meier method. The protocol specifies only that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided as a summary of the distributions.
Analysis population: Eligible participants
Groups in this outcome
Sorafenib Alone
400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
SBRT Followed by Sorafenib
27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Sorafenib Alone | 92 |
| SBRT Followed by Sorafenib | 85 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib Alone | 5.49 | Not reported | 3.42 | 6.28 | Not reported |
| SBRT Followed by Sorafenib | 9.22 | Not reported | 7.53 | 11.89 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.40
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.75
- estimate Comment
- Reference arm = Sorafenib Alone
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0001
- p Value Comment
- Two-sided significance level=0.05
- param Type
- Hazard Ratio (HR)
- param Value
- 0.55
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.40
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.75
- estimate Comment
- Reference arm = Sorafenib Alone
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0001
- p Value Comment
- Two-sided significance level=0.05
- param Type
- Hazard Ratio (HR)
- param Value
- 0.55
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.42
- upper Limit
- 6.28
- value
- 5.49
- group Id
- OG001
- lower Limit
- 7.53
- upper Limit
- 11.89
- value
- 9.22
- denoms
- counts
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 85
- units
- Participants
- description
- Failure for progression-free survival (PFS) include death, new tumor thrombosis, progression of hepatocellular carcinoma (HCC) within liver excluding tumor thrombosis status, progression of distant Mets that were present at study entry, new HCC within liver including tumor thrombosis, and vascular thrombosis events =progression-new enhancing tumor thrombosis/progression-Increase in the volume of enhancing portion of thrombosis. PFS time is defined as the time from randomization to the date of first failure, date of death, or last known follow-up (censored). PFS rates are estimated by the Kaplan-Meier method. The protocol specifies only that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided as a summary of the distributions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Sorafenib Alone
- description
- 27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- SBRT Followed by Sorafenib
- param Type
- NUMBER
- population Description
- Eligible participants
- reporting Status
- POSTED
- time Frame
- From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice