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NCT02839343 · OUTCOME

Residual Tumor (R)0 Resection Rate

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
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
24 months

What was measured

Defined as the percentage of patients in whom an achieved R0 resection was achieved during surgery.

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 percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 (mFOLFIRINOX + Surgery + FOLFOX)49Not reportedNot reportedNot reportedNot reported
Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx)35Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        35
denoms
  1. counts
    1. group Id
      OG000
      value
      65
    2. group Id
      OG001
      value
      55
    units
    Participants
description
Defined as the percentage of patients in whom an achieved R0 resection was achieved during surgery.
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
NUMBER
population Description
Excluded from analysis were 6 patients that withdrew or progressed prior to treatment.
reporting Status
POSTED
time Frame
24 months
title
Residual Tumor (R)0 Resection Rate
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice