TriangleNCT00970502 · OUTCOME
Clinical Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 20 months
What was measured
Response to Concurrent Erlotinib, Celecoxib, and Reirradiation according to Response Evaluation Criteria in Solid Tumors - Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Groups in this outcome
Erlotinib + Celecoxib
erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
| Group | Source count |
|---|---|
| Erlotinib + Celecoxib | 14 |
Reported measurements
Complete Response(CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Erlotinib + Celecoxib | 6 | Not reported | Not reported | Not reported | Not reported |
Pathologic partial response (pPR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Erlotinib + Celecoxib | 1 | Not reported | Not reported | Not reported | Not reported |
Progressive disease (PD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Erlotinib + Celecoxib | 5 | Not reported | Not reported | Not reported | Not reported |
No evidence of disease (NED)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Erlotinib + Celecoxib | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- Complete Response(CR)
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Pathologic partial response (pPR)
- categories
- measurements
- group Id
- OG000
- value
- 5
- title
- Progressive disease (PD)
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- No evidence of disease (NED)
- denoms
- counts
- group Id
- OG000
- value
- 14
- units
- Participants
- description
- Response to Concurrent Erlotinib, Celecoxib, and Reirradiation according to Response Evaluation Criteria in Solid Tumors - Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
- groups
- description
- erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
- id
- OG000
- title
- Erlotinib + Celecoxib
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 20 months
- title
- Clinical Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice