TriangleNCT02839343 · OUTCOME
Pathologic Complete Rate (pCR) Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- Not reported
- Time frame
- 24 months
What was measured
Defined as the percentage of patients in whom a pCR was confirmed by histopathologic review of the surgical specimen. Chi-square test (or Fisher's exact test if the data in contingency table is sparse) will be used to compare pCR resection rate between two treatment arms. Sensitivity analysis will be conducted among patients in cohort 1) and cohort 2). The association between pCR rate and OS/progression free survival (PFS) will be assessed by log-rank test and Cox model.
Analysis population: Excluded from analysis were 6 patients that withdrew or progressed prior to treatment.
Groups in this outcome
Arm 1 (mFOLFIRINOX + Surgery + FOLFOX)
Patients receive 8 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx)
Patients receive 7 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients receive radiation therapy then undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
| Group | Source count |
|---|---|
| Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 65 |
| Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx) | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 55
- units
- Participants
- description
- Defined as the percentage of patients in whom a pCR was confirmed by histopathologic review of the surgical specimen. Chi-square test (or Fisher's exact test if the data in contingency table is sparse) will be used to compare pCR resection rate between two treatment arms. Sensitivity analysis will be conducted among patients in cohort 1) and cohort 2). The association between pCR rate and OS/progression free survival (PFS) will be assessed by log-rank test and Cox model.
- groups
- description
- Patients receive 8 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
- id
- OG000
- title
- Arm 1 (mFOLFIRINOX + Surgery + FOLFOX)
- description
- Patients receive 7 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients receive radiation therapy then undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
- id
- OG001
- title
- Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx)
- param Type
- NUMBER
- population Description
- Excluded from analysis were 6 patients that withdrew or progressed prior to treatment.
- reporting Status
- POSTED
- time Frame
- 24 months
- title
- Pathologic Complete Rate (pCR) Rate
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice