TriangleNCT00667342 · OUTCOME
Number of Participants With Unacceptable Toxicity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- After all patients have completed therapy, up to 1 year after last patient is enrolled
What was measured
Objective: To study the feasibility of combining: 1) bevacizumab with cisplatin, doxorubicin, and high-dose methotrexate (MAP) in patients with localized resectable osteosarcoma; and 2) bevacizumab with MAP and ifosfamide, and etoposide in patients with unresectable or metastatic osteosarcoma. The target unacceptable toxicity is defined as grade 4 hypertension, proteinuria, or bleeding excluding petechiae/purpura, grade 3/4 thrombosis/embolism excluding catheter-related thrombosis. The unacceptable toxicity for major wound complication is defined as grade 2, 3, or 4 major wound complications. A six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity.
Analysis population: Due to slow accrual, the trial was closed to accrual early. Thus, only 31 stratum A patients and 12 stratum B or C patients were enrolled on the study. Therefore, based on the number of patients enrolled and the designed power for the study, we do not have confidence in making a conclusion regarding this feasibility objective.
Groups in this outcome
A: Localized Resectable Disease
Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
C: Metastatic Tumors
Stratum C participants had metastatic tumors.
| Group | Source count |
|---|---|
| A: Localized Resectable Disease | 31 |
| C: Metastatic Tumors | 11 |
Reported measurements
Grade 4 Hypertension
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A: Localized Resectable Disease | 0 | Not reported | Not reported | Not reported | Not reported |
| C: Metastatic Tumors | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 4 Proteinuria
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A: Localized Resectable Disease | 0 | Not reported | Not reported | Not reported | Not reported |
| C: Metastatic Tumors | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 4 Bleeding
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A: Localized Resectable Disease | 0 | Not reported | Not reported | Not reported | Not reported |
| C: Metastatic Tumors | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 3/4 Thrombosis/Embolism
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A: Localized Resectable Disease | 1 | Not reported | Not reported | Not reported | Not reported |
| C: Metastatic Tumors | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 2, 3 or 4 Major Wound Complication
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A: Localized Resectable Disease | 7 | Not reported | Not reported | Not reported | Not reported |
| C: Metastatic Tumors | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4 Hypertension
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4 Proteinuria
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4 Bleeding
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Grade 3/4 Thrombosis/Embolism
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 2
- title
- Grade 2, 3 or 4 Major Wound Complication
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 11
- units
- Participants
- description
- Objective: To study the feasibility of combining: 1) bevacizumab with cisplatin, doxorubicin, and high-dose methotrexate (MAP) in patients with localized resectable osteosarcoma; and 2) bevacizumab with MAP and ifosfamide, and etoposide in patients with unresectable or metastatic osteosarcoma. The target unacceptable toxicity is defined as grade 4 hypertension, proteinuria, or bleeding excluding petechiae/purpura, grade 3/4 thrombosis/embolism excluding catheter-related thrombosis. The unacceptable toxicity for major wound complication is defined as grade 2, 3, or 4 major wound complications. A six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity.
- groups
- description
- Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
- id
- OG000
- title
- A: Localized Resectable Disease
- description
- Stratum C participants had metastatic tumors.
- id
- OG001
- title
- C: Metastatic Tumors
- param Type
- NUMBER
- population Description
- Due to slow accrual, the trial was closed to accrual early. Thus, only 31 stratum A patients and 12 stratum B or C patients were enrolled on the study. Therefore, based on the number of patients enrolled and the designed power for the study, we do not have confidence in making a conclusion regarding this feasibility objective.
- reporting Status
- POSTED
- time Frame
- After all patients have completed therapy, up to 1 year after last patient is enrolled
- title
- Number of Participants With Unacceptable Toxicity
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice