TriangleNCT01064479 · OUTCOME
Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])
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
- 5 years
What was measured
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
Groups in this outcome
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
Arm B (Combination Chemotherapy and Placebo)
Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
| Group | Source count |
|---|---|
| Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | 60 |
| Arm B (Combination Chemotherapy and Placebo) | 59 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Combination Chemotherapy and Placebo) | 5 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | 27 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Combination Chemotherapy and Placebo) | 19 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | 8 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Combination Chemotherapy and Placebo) | 13 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | 16 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Combination Chemotherapy and Placebo) | 17 | Not reported | Not reported | Not reported | Not reported |
Inevaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) | 5 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Combination Chemotherapy and Placebo) | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 19
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 13
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 17
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- title
- Inevaluable
- denoms
- counts
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 59
- units
- Participants
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
- groups
- description
- Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
- id
- OG000
- title
- Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
- description
- Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
- id
- OG001
- title
- Arm B (Combination Chemotherapy and Placebo)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 5 years
- title
- Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice