NCT04030455 · OUTCOME
To Determine the 2-year Relapse-free Survival (RFS) and Overall Survival (OS) in the Overall Population and in the Subgroup Who Achieves a pCR (RFS)
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
- 95% Confidence Interval
- Time frame
- from first study registration to recurrence after local therapy or death from any cause (up to 2 years follow up)
What was measured
Relapse free survival is defined as the time from study registration to recurrence after local therapy or death from any cause. Recurrence was counted only if it occurred after definitive local therapy (surgery and/or radiotherapy). Patients achieving durable complete responses to PCD without local therapy, and patients receiving local therapy without subsequent recurrence, were censored at last follow-up.
Groups in this outcome
Experimental (Cis/Doce/Pembro)
cis 75 mg/m2 (SOC), doce 74 mg/m2 (SOC), pembro 200mg (Exp), Q3W IV
PCR Participants
Out of the experimental group these subjects had pathological complete response
| Group | Source count |
|---|---|
| Experimental (Cis/Doce/Pembro) | 24 |
| PCR Participants | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Experimental (Cis/Doce/Pembro) | 0.75 | Not reported | 0.58 | 0.92 | Not reported |
| PCR Participants | 0.79 | Not reported | 0.61 | 0.97 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.58
- upper Limit
- 0.92
- value
- 0.75
- group Id
- OG001
- lower Limit
- 0.61
- upper Limit
- 0.97
- value
- 0.79
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 19
- units
- Participants
- description
- Relapse free survival is defined as the time from study registration to recurrence after local therapy or death from any cause. Recurrence was counted only if it occurred after definitive local therapy (surgery and/or radiotherapy). Patients achieving durable complete responses to PCD without local therapy, and patients receiving local therapy without subsequent recurrence, were censored at last follow-up.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- cis 75 mg/m2 (SOC), doce 74 mg/m2 (SOC), pembro 200mg (Exp), Q3W IV
- id
- OG000
- title
- Experimental (Cis/Doce/Pembro)
- description
- Out of the experimental group these subjects had pathological complete response
- id
- OG001
- title
- PCR Participants
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- from first study registration to recurrence after local therapy or death from any cause (up to 2 years follow up)
- title
- To Determine the 2-year Relapse-free Survival (RFS) and Overall Survival (OS) in the Overall Population and in the Subgroup Who Achieves a pCR (RFS)
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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