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NCT02040142 · OUTCOME

Completeness of Cytoreduction

HIPEC for Peritoneal Carcinomatosis · Source last updated 2024-10-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up through study discontinuation or 12 months after study treatment, whichever occurs first

What was measured

Completeness of cytoreduction will be estimated and recorded using a complete cytoreduction (CC) which corresponds to a residual disease (RR) score. Completeness of Cytoreduction (CC) scores range from CC0 - CC3 and correlate to residual disease as follows: CC0 = R0: No Disease, complete removal of all visible tumor with negative cytology or microscopic margin CC1 = R1: \<= 0.25 cm; complete removal of all visible tumor with positive cytology or microscopic margin CC2 = R2a: 0.25-2.5 cm; minimal residual tumor, nodule(s) ≤ 0.5 cm CC3 =R2b: \>=2.5 cm; gross residual tumor, nodule(s), \> 0.5, but ≤ 2 cm CC3 =R2c: \>=2.5 cm; extensive disease remaining, nodule(s) \> 2 cm

Analysis population: Data was not collected and therefore Completeness of Cytoreduction was never able to be estimated.

Groups in this outcome

HIPEC + Mitomycin C

HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C

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

Analysis denominator · Participants

GroupSource count
HIPEC + Mitomycin C0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
Completeness of cytoreduction will be estimated and recorded using a complete cytoreduction (CC) which corresponds to a residual disease (RR) score. Completeness of Cytoreduction (CC) scores range from CC0 - CC3 and correlate to residual disease as follows: CC0 = R0: No Disease, complete removal of all visible tumor with negative cytology or microscopic margin CC1 = R1: \<= 0.25 cm; complete removal of all visible tumor with positive cytology or microscopic margin CC2 = R2a: 0.25-2.5 cm; minimal residual tumor, nodule(s) ≤ 0.5 cm CC3 =R2b: \>=2.5 cm; gross residual tumor, nodule(s), \> 0.5, but ≤ 2 cm CC3 =R2c: \>=2.5 cm; extensive disease remaining, nodule(s) \> 2 cm
groups
  1. description
    HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C
    id
    OG000
    title
    HIPEC + Mitomycin C
population Description
Data was not collected and therefore Completeness of Cytoreduction was never able to be estimated.
reporting Status
POSTED
time Frame
Up through study discontinuation or 12 months after study treatment, whichever occurs first
title
Completeness of Cytoreduction
type
PRIMARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice