TriangleNCT01730937 · OUTCOME
Best Vascular Thrombosis Response up to the Time of Progressive Disease (if Applicable)
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
- From randomization to last follow-up. Imaging occurs every 3 months for two years then every six months. Maximum follow-up at time of analysis was 7.6 years.
What was measured
Complete response: Complete resolution of thrombosis, with recanalization of vessel. Partial response (PR): * Partial recanalization (if prior complete blockage) * Unequivocal reduction in the maximal girth * Unequivocal reduction in the volume, or elimination, of arterial enhancing portion Progressive disease (PD): any unequivocal, unambiguous * New enhancing tumor thrombosis * Increase in the volume of enhancing portion * Unequivocal progression of thrombosis (non-measurable disease), the increase in overall tumor burden (enhancing thrombosis) must be comparable to the increase required for the Response Evaluation Criteria in Solid Tumor 1.1 definition of PD of measurable disease (e.g. ≥ 73% increase in volume, which is similar to 20% increase in diameter, and at least a 5 mm absolute increase). Stable disease: * No/small changes that do not meet the above criteria for PR or PD * Increase in the volume of non-enhancing thrombosis * New bland non-enhancing thrombosis
Analysis population: Eligible participants who had vascular thrombosis at study entry
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 | 66 |
| SBRT Followed by Sorafenib | 62 |
Reported measurements
Source class 1
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib Alone | 0 | Not reported | Not reported | Not reported | Not reported |
| SBRT Followed by Sorafenib | 2 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib Alone | 6 | Not reported | Not reported | Not reported | Not reported |
| SBRT Followed by Sorafenib | 22 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib Alone | 25 | Not reported | Not reported | Not reported | Not reported |
| SBRT Followed by Sorafenib | 23 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib Alone | 14 | Not reported | Not reported | Not reported | Not reported |
| SBRT Followed by Sorafenib | 4 | Not reported | Not reported | Not reported | Not reported |
Unknown
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib Alone | 21 | Not reported | Not reported | Not reported | Not reported |
| SBRT Followed by Sorafenib | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- Complete Response
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 22
- title
- Partial Response
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 23
- title
- Stable Disease
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 4
- title
- Progressive Disease
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 11
- title
- Unknown
- denoms
- counts
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 62
- units
- Participants
- description
- Complete response: Complete resolution of thrombosis, with recanalization of vessel. Partial response (PR): * Partial recanalization (if prior complete blockage) * Unequivocal reduction in the maximal girth * Unequivocal reduction in the volume, or elimination, of arterial enhancing portion Progressive disease (PD): any unequivocal, unambiguous * New enhancing tumor thrombosis * Increase in the volume of enhancing portion * Unequivocal progression of thrombosis (non-measurable disease), the increase in overall tumor burden (enhancing thrombosis) must be comparable to the increase required for the Response Evaluation Criteria in Solid Tumor 1.1 definition of PD of measurable disease (e.g. ≥ 73% increase in volume, which is similar to 20% increase in diameter, and at least a 5 mm absolute increase). Stable disease: * No/small changes that do not meet the above criteria for PR or PD * Increase in the volume of non-enhancing thrombosis * New bland non-enhancing thrombosis
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Eligible participants who had vascular thrombosis at study entry
- reporting Status
- POSTED
- time Frame
- From randomization to last follow-up. Imaging occurs every 3 months for two years then every six months. Maximum follow-up at time of analysis was 7.6 years.
- title
- Best Vascular Thrombosis Response up to the Time of Progressive Disease (if Applicable)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice