TriangleNCT00061893 · OUTCOME
Occurrence of Severe 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
- The first two cycles (6 weeks) of protocol chemotherapy
What was measured
An incidence of severe toxicity is defined to be the occurrence of grade 3 or higher infection or grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy. If 12 or more patients experience grade 3 or higher infection or five or more patients experience grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy, the regimen will be flagged as being associated with an excessive rate of severe toxicity.
Analysis population: By protocol design, all eligible patients who received protocol therapy were considered in the evaluation of severe toxicity. Three (3) patients were considered ineligible. All other patients (35) started protocol therapy and are thus included in the evaluation for this measure.
Groups in this outcome
Combination Chemotherapy
Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
| Group | Source count |
|---|---|
| Combination Chemotherapy | 35 |
Reported measurements
Grade 3 or Higher Infection
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Chemotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
Grade 3 or Higher Sensory Neuropathy
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Chemotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Grade 3 or Higher Infection
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Grade 3 or Higher Sensory Neuropathy
- denoms
- counts
- group Id
- OG000
- value
- 35
- units
- Participants
- description
- An incidence of severe toxicity is defined to be the occurrence of grade 3 or higher infection or grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy. If 12 or more patients experience grade 3 or higher infection or five or more patients experience grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy, the regimen will be flagged as being associated with an excessive rate of severe toxicity.
- groups
- description
- Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
- id
- OG000
- title
- Combination Chemotherapy
- param Type
- NUMBER
- population Description
- By protocol design, all eligible patients who received protocol therapy were considered in the evaluation of severe toxicity. Three (3) patients were considered ineligible. All other patients (35) started protocol therapy and are thus included in the evaluation for this measure.
- reporting Status
- POSTED
- time Frame
- The first two cycles (6 weeks) of protocol chemotherapy
- title
- Occurrence of Severe Toxicity
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice