TriangleNCT00652899 · OUTCOME
Number of Patients Per Disease Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Patients
- Interval / dispersion
- Not reported
- Time frame
- 1 Month After Natural Killer Cell Infusion (Day 30)
What was measured
Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Complete Response (CR)-Disappearance of all target lesions (TL); Partial Response (PR)-\< or = 30% decrease in the sum of the longest diameter (LD) of TL, reference baseline sum LD; Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference the smallest sum LD since the treatment started; Progressive Disease (PD)- \< or = 20% increase in the sum of the LD of TL, reference the smallest sum LD recorded since treatment started or appearance of \< or = 1 new lesion.
Analysis population: Includes 12 patients that completed treatment per protocol criteria.
Groups in this outcome
No Total Body Irradiation
This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m\^2 and fludarabine 25 mg/m\^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 \* 10\^7 kg) and no total body irradiation.
Total Body Irradiation
This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m\^2 and fludarabine 25 mg/m\^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 \* 10\^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
| Group | Source count |
|---|---|
| No Total Body Irradiation | 7 |
| Total Body Irradiation | 5 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| No Total Body Irradiation | 0 | Not reported | Not reported | Not reported | Not reported |
| Total Body Irradiation | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| No Total Body Irradiation | 2 | Not reported | Not reported | Not reported | Not reported |
| Total Body Irradiation | 1 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| No Total Body Irradiation | 4 | Not reported | Not reported | Not reported | Not reported |
| Total Body Irradiation | 4 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| No Total Body Irradiation | 1 | Not reported | Not reported | Not reported | Not reported |
| Total Body Irradiation | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- anticipated Posting Date
- 2010-05
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Progressive Disease
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Complete Response (CR)-Disappearance of all target lesions (TL); Partial Response (PR)-\< or = 30% decrease in the sum of the longest diameter (LD) of TL, reference baseline sum LD; Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference the smallest sum LD since the treatment started; Progressive Disease (PD)- \< or = 20% increase in the sum of the LD of TL, reference the smallest sum LD recorded since treatment started or appearance of \< or = 1 new lesion.
- groups
- description
- This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m\^2 and fludarabine 25 mg/m\^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 \* 10\^7 kg) and no total body irradiation.
- id
- OG000
- title
- No Total Body Irradiation
- description
- This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m\^2 and fludarabine 25 mg/m\^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 \* 10\^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
- id
- OG001
- title
- Total Body Irradiation
- param Type
- NUMBER
- population Description
- Includes 12 patients that completed treatment per protocol criteria.
- reporting Status
- POSTED
- time Frame
- 1 Month After Natural Killer Cell Infusion (Day 30)
- title
- Number of Patients Per Disease Response
- type
- SECONDARY
- unit Of Measure
- Patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice