Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02839343 · OUTCOME

Event-free Survival

Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer · Source last updated 2022-05-24

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
4 years and 7 months

What was measured

Defined as time from randomization to the first documentation of event where events considered are 1) disease progression, per RECIST, prior to surgery, 2) surgery with R2 resection, 3) recurrent disease following surgery, or 4) death due to any cause. Will be estimated using the method of Kaplan-Meier in each arm and compared between treatment groups using the log-rank test. The correlation between pathologic complete response (pCR) status and event-free survival time will be assessed by Cox model with landmark approach.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm 1 (mFOLFIRINOX + Surgery + FOLFOX)65
Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx)55

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm 1 (mFOLFIRINOX + Surgery + FOLFOX)15.0Not reported11.221.9Not reported
Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx)10.2Not reported6.717.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.2
        upper Limit
        21.9
        value
        15.0
      2. group Id
        OG001
        lower Limit
        6.7
        upper Limit
        17.3
        value
        10.2
denoms
  1. counts
    1. group Id
      OG000
      value
      65
    2. group Id
      OG001
      value
      55
    units
    Participants
description
Defined as time from randomization to the first documentation of event where events considered are 1) disease progression, per RECIST, prior to surgery, 2) surgery with R2 resection, 3) recurrent disease following surgery, or 4) death due to any cause. Will be estimated using the method of Kaplan-Meier in each arm and compared between treatment groups using the log-rank test. The correlation between pathologic complete response (pCR) status and event-free survival time will be assessed by Cox model with landmark approach.
dispersion Type
95% Confidence Interval
groups
  1. 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)
  2. 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
MEDIAN
population Description
Excluded from analysis were 6 patients that withdrew or progressed prior to treatment.
reporting Status
POSTED
time Frame
4 years and 7 months
title
Event-free Survival
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice