TriangleNCT05185947 · OUTCOME
Proportion of Participants Who Are Successfully Down-staged to Resectable by Use of Chemotherapy Reported Along With a 95% Confidence Interval.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline, every 9 weeks during treatment, and then every 3 months, up to 2 years
What was measured
The proportion of participants who are successfully down-staged to resectable by use of chemotherapy will be reported along with a 95% confidence interval. This outcome measure evaluates how many participants with initially inoperable (unresectable) peritoneal carcinomatosis became eligible for surgery after receiving bidirectional chemotherapy (intravenous and intraperitoneal paclitaxel and oral nilotinib).
Analysis population: 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.
Groups in this outcome
Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.
Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1
Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1
Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).
| Group | Source count |
|---|---|
| Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 4 |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 1 |
| Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | 1 |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 0 | Not reported | 0 | 0 | Not reported |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 0 | Not reported | 0 | 0 | Not reported |
| Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | 0 | Not reported | 0 | 0 | Not reported |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | 0 | Not reported | 0 | 0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG003
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- units
- Participants
- description
- The proportion of participants who are successfully down-staged to resectable by use of chemotherapy will be reported along with a 95% confidence interval. This outcome measure evaluates how many participants with initially inoperable (unresectable) peritoneal carcinomatosis became eligible for surgery after receiving bidirectional chemotherapy (intravenous and intraperitoneal paclitaxel and oral nilotinib).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).
- id
- OG000
- title
- Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
- description
- Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.
- id
- OG001
- title
- Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
- description
- Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
- id
- OG002
- title
- Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1
- description
- Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).
- id
- OG003
- title
- Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1
- param Type
- NUMBER
- population Description
- 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.
- reporting Status
- POSTED
- time Frame
- Baseline, every 9 weeks during treatment, and then every 3 months, up to 2 years
- title
- Proportion of Participants Who Are Successfully Down-staged to Resectable by Use of Chemotherapy Reported Along With a 95% Confidence Interval.
- type
- PRIMARY
- unit Of Measure
- proportion of participants
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Preserved source evidence · Not medical advice