TriangleNCT01730937 · OUTCOME
Percentage of Participants With Improvement in the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Total Score 6 Months After the Start of Treatment
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 and 6 months
What was measured
The FACT-Hep total score measures quality of life in patients with hepatobiliary cancer. Possible scores range from 0 to 180, with higher scores indicating a better outcome. Improvement in FACT-Hep total score is defined as an increase from the baseline to 6-month score of at least 5 points.
Analysis population: Eligible participants who consented to the quality of life component and had data at baseline and six months.
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 | 20 |
| SBRT Followed by Sorafenib | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib Alone | 10 | Not reported | 2 | 31 | Not reported |
| SBRT Followed by Sorafenib | 35 | Not reported | 17 | 59 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2
- upper Limit
- 31
- value
- 10
- group Id
- OG001
- lower Limit
- 17
- upper Limit
- 59
- value
- 35
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 17
- units
- Participants
- description
- The FACT-Hep total score measures quality of life in patients with hepatobiliary cancer. Possible scores range from 0 to 180, with higher scores indicating a better outcome. Improvement in FACT-Hep total score is defined as an increase from the baseline to 6-month score of at least 5 points.
- 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 who consented to the quality of life component and had data at baseline and six months.
- reporting Status
- POSTED
- time Frame
- Baseline and 6 months
- title
- Percentage of Participants With Improvement in the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Total Score 6 Months After the Start of Treatment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice