TriangleNCT00476476 · OUTCOME
Response Rate
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
- 90% Confidence Interval
- Time frame
- Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts).
What was measured
Response is defined as achieving complete or partial response.Complete response (CR) for both cohorts was defined as resolution of all identified tumor masses on the vulva or disappearance of all target and non-target lesions with no evidence of new lesions documented by two disease assessments at least 4 weeks apart. For cohort 1 pts, a partial response (PR) was defined as a 30% reduction in the product of all diameters of the vulva tumor/tumors compared to baseline measurements. For cohort 2 pts, PR defined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was at least a 30% decrease in the sum of the longest diameter (LD) of all target measurable lesions (baseline sum LD reference).
Analysis population: The analysis dataset is comprised of response evaluable patients.
Groups in this outcome
Erlotinib-Cohort 1
Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
Erlotinib-Cohort 2
Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
| Group | Source count |
|---|---|
| Erlotinib-Cohort 1 | 17 |
| Erlotinib-Cohort 2 | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Erlotinib-Cohort 1 | .35 | Not reported | .167 | .580 | Not reported |
| Erlotinib-Cohort 2 | .22 | Not reported | .09 | .404 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- .167
- upper Limit
- .580
- value
- .35
- group Id
- OG001
- lower Limit
- .09
- upper Limit
- .404
- value
- .22
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 23
- units
- Participants
- description
- Response is defined as achieving complete or partial response.Complete response (CR) for both cohorts was defined as resolution of all identified tumor masses on the vulva or disappearance of all target and non-target lesions with no evidence of new lesions documented by two disease assessments at least 4 weeks apart. For cohort 1 pts, a partial response (PR) was defined as a 30% reduction in the product of all diameters of the vulva tumor/tumors compared to baseline measurements. For cohort 2 pts, PR defined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was at least a 30% decrease in the sum of the longest diameter (LD) of all target measurable lesions (baseline sum LD reference).
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
- id
- OG000
- title
- Erlotinib-Cohort 1
- description
- Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
- id
- OG001
- title
- Erlotinib-Cohort 2
- param Type
- NUMBER
- population Description
- The analysis dataset is comprised of response evaluable patients.
- reporting Status
- POSTED
- time Frame
- Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts).
- title
- Response Rate
- type
- PRIMARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice