TriangleNCT01822496 · OUTCOME
Local-regional Progression-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to study termination. Maximum follow-up was 39.0 months
What was measured
Progression is defined using the RECIST guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new regional lesions. Local progression is defined as progression within the planning target volume (PTV). Regional progression is defined as progression outside of the PTV but within the same lobe of the lung as the primary tumor or in regional lymph nodes as defined by the American Joint Committee on Cancer (AJCC) 7th edition nodal stations. Local-regional progression-free survival time is measured from the date of randomization to the date of first local-regional progression, death, or last known follow-up (censored). Local-regional progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination.
Analysis population: Eligible patients
Groups in this outcome
EGFR: Erlotinib
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
EGFR: No Erlotinib
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
ALK: Crizotinib
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
ALK: No Crizotinib
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
| Group | Source count |
|---|---|
| EGFR: Erlotinib | 14 |
| EGFR: No Erlotinib | 21 |
| ALK: Crizotinib | 9 |
| ALK: No Crizotinib | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EGFR: Erlotinib | 25.7 | Not reported | 8.5 | NA | Not reached |
| EGFR: No Erlotinib | NA | Not reported | NA | NA | Not reached |
| ALK: Crizotinib | 14.7 | Not reported | 6.4 | 19.5 | Not reported |
| ALK: No Crizotinib | NA | Not reported | NA | NA | Not reached |
Complete source fields
- classes
- categories
- measurements
- comment
- Not reached
- group Id
- OG000
- lower Limit
- 8.5
- upper Limit
- NA
- value
- 25.7
- comment
- Not reached
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG002
- lower Limit
- 6.4
- upper Limit
- 19.5
- value
- 14.7
- comment
- Not reached
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 7
- units
- Participants
- description
- Progression is defined using the RECIST guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new regional lesions. Local progression is defined as progression within the planning target volume (PTV). Regional progression is defined as progression outside of the PTV but within the same lobe of the lung as the primary tumor or in regional lymph nodes as defined by the American Joint Committee on Cancer (AJCC) 7th edition nodal stations. Local-regional progression-free survival time is measured from the date of randomization to the date of first local-regional progression, death, or last known follow-up (censored). Local-regional progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
- id
- OG000
- title
- EGFR: Erlotinib
- description
- Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
- id
- OG001
- title
- EGFR: No Erlotinib
- description
- Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
- id
- OG002
- title
- ALK: Crizotinib
- description
- Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
- id
- OG003
- title
- ALK: No Crizotinib
- param Type
- MEDIAN
- population Description
- Eligible patients
- reporting Status
- POSTED
- time Frame
- From randomization to study termination. Maximum follow-up was 39.0 months
- title
- Local-regional Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice