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NCT01730586 · OUTCOME

Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA)

Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas · Source last updated 2020-01-18

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Assessed at 21 day cycle; Restaging done every 3 cycles

What was measured

Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1, 2009): Complete Response (CR): Disappearance all lesions including normalization of elevated tumor marker level; Pathological lymph nodes reduction in short axis to \<10 mm. Partial Response (PR): \>30% decrease sum longest diameters (LD) of lesions reference baseline sum LD. Progressive Disease (PD): \>20% increase (absolute increase \>5 mm) in sum LD measured lesions references smallest sum LD, and appearance new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD. After a tumor demonstrates a tumor response (partial or complete), confirmation of the response obtained by a second evaluation to be performed 2 cycles later (+/- 1week) \[second tumor assessment not \<4 weeks from response observed\]. Assessed via computed tomography (CT) of the chest, abdomen, and pelvis.

Analysis population: In the CIMP-CRC arm 15 participants were considered efficacy evaluable \[Of 21 treated, 6 participants were withdrawn due to toxicity (2) and due to clinical progression (4)\], and three were not evaluable in SBA arm.

Groups in this outcome

CIMP-high Colorectal Cancer

Abraxane 220 mg/m\^2 intravenously on Day 1 of 21 day cycle.

Small Bowel Adenocarcinoma (SBA)

Abraxane 220 mg/m\^2 intravenously on Day 1 of 21 day cycle.

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

Analysis denominator · Participants

GroupSource count
CIMP-high Colorectal Cancer15
Small Bowel Adenocarcinoma (SBA)10

Reported measurements

Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CIMP-high Colorectal Cancer0Not reportedNot reportedNot reportedNot reported
Small Bowel Adenocarcinoma (SBA)0Not reportedNot reportedNot reportedNot reported
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CIMP-high Colorectal Cancer0Not reportedNot reportedNot reportedNot reported
Small Bowel Adenocarcinoma (SBA)2Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CIMP-high Colorectal Cancer3Not reportedNot reportedNot reportedNot reported
Small Bowel Adenocarcinoma (SBA)3Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CIMP-high Colorectal Cancer12Not reportedNot reportedNot reportedNot reported
Small Bowel Adenocarcinoma (SBA)5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
    title
    Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        5
    title
    Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      10
    units
    Participants
description
Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1, 2009): Complete Response (CR): Disappearance all lesions including normalization of elevated tumor marker level; Pathological lymph nodes reduction in short axis to \<10 mm. Partial Response (PR): \>30% decrease sum longest diameters (LD) of lesions reference baseline sum LD. Progressive Disease (PD): \>20% increase (absolute increase \>5 mm) in sum LD measured lesions references smallest sum LD, and appearance new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD. After a tumor demonstrates a tumor response (partial or complete), confirmation of the response obtained by a second evaluation to be performed 2 cycles later (+/- 1week) \[second tumor assessment not \<4 weeks from response observed\]. Assessed via computed tomography (CT) of the chest, abdomen, and pelvis.
groups
  1. description
    Abraxane 220 mg/m\^2 intravenously on Day 1 of 21 day cycle.
    id
    OG000
    title
    CIMP-high Colorectal Cancer
  2. description
    Abraxane 220 mg/m\^2 intravenously on Day 1 of 21 day cycle.
    id
    OG001
    title
    Small Bowel Adenocarcinoma (SBA)
param Type
COUNT_OF_PARTICIPANTS
population Description
In the CIMP-CRC arm 15 participants were considered efficacy evaluable \[Of 21 treated, 6 participants were withdrawn due to toxicity (2) and due to clinical progression (4)\], and three were not evaluable in SBA arm.
reporting Status
POSTED
time Frame
Assessed at 21 day cycle; Restaging done every 3 cycles
title
Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice