NCT02611037 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 3 years
What was measured
Overall survival defined as the time from the first day of transarterial chemoperfusion treatment to death.
Analysis population: All evaluable participants. Study patients cannot be analyzed separately. No dose limiting toxicities observed, therefore all participants received same dosing.
Groups in this outcome
Chemoperfusion + Questionnaire
Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin. Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2). Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine. Lung Cancer Symptom Scale for Mesothelioma Questionnaire: Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.
| Group | Source count |
|---|---|
| Chemoperfusion + Questionnaire | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemoperfusion + Questionnaire | 8.9 | Not reported | 5.7 | 15 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.7
- upper Limit
- 15
- value
- 8.9
- denoms
- counts
- group Id
- OG000
- value
- 32
- units
- Participants
- description
- Overall survival defined as the time from the first day of transarterial chemoperfusion treatment to death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin. Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2). Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine. Lung Cancer Symptom Scale for Mesothelioma Questionnaire: Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.
- id
- OG000
- title
- Chemoperfusion + Questionnaire
- param Type
- MEDIAN
- population Description
- All evaluable participants. Study patients cannot be analyzed separately. No dose limiting toxicities observed, therefore all participants received same dosing.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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