TriangleNCT00639769 · OUTCOME
Patient Response
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
- 6 weeks after last chemotherapy treatment
What was measured
Number of patients in each response category according to RECIST criteria: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Analysis population: Analysis was per protocol (7 patients did not receive a full cycle of treatment, and 1 patient was censored for incomplete records)
Groups in this outcome
Therapeutic Intervention
Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
| Group | Source count |
|---|---|
| Therapeutic Intervention | 32 |
Reported measurements
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Therapeutic Intervention | 11 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Therapeutic Intervention | 15 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Therapeutic Intervention | 6 | Not reported | Not reported | Not reported | Not reported |
Complete response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Therapeutic Intervention | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 11
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 15
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Complete response
- denoms
- counts
- group Id
- OG000
- value
- 32
- units
- Participants
- description
- Number of patients in each response category according to RECIST criteria: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
- groups
- description
- Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
- id
- OG000
- title
- Therapeutic Intervention
- param Type
- NUMBER
- population Description
- Analysis was per protocol (7 patients did not receive a full cycle of treatment, and 1 patient was censored for incomplete records)
- reporting Status
- POSTED
- time Frame
- 6 weeks after last chemotherapy treatment
- title
- Patient Response
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice