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NCT00112489 · OUTCOME

Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response

Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer · Source last updated 2018-09-25

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Response was measured every other cycle (q 6 weeks) until disease progression is documented.

What was measured

Primary outcome measured according to RECIST v1.0 Best Response: Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

Analysis population: Total eligible and treated participants

Groups in this outcome

Paclitaxel Followed by Carboplatin

Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy

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

Analysis denominator · Participants

GroupSource count
Paclitaxel Followed by Carboplatin46

Reported measurements

Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel Followed by Carboplatin6Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel Followed by Carboplatin19Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel Followed by Carboplatin11Not reportedNot reportedNot reportedNot reported
Disease Progression
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel Followed by Carboplatin6Not reportedNot reportedNot reportedNot reported
Indeterminate
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel Followed by Carboplatin4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Disease Progression
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Indeterminate
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    units
    Participants
description
Primary outcome measured according to RECIST v1.0 Best Response: Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
groups
  1. description
    Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
    id
    OG000
    title
    Paclitaxel Followed by Carboplatin
param Type
NUMBER
population Description
Total eligible and treated participants
reporting Status
POSTED
time Frame
Response was measured every other cycle (q 6 weeks) until disease progression is documented.
title
Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice