Skip to content
← Full study record

NCT00002558 · OUTCOME

Overall Objective Response

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors · Source last updated 2016-05-23

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
2 years

What was measured

Overall Objective Response will be assessed prior to dose-intensive therapy and at the completion of therapy. Complete disappearance of all clinical, radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy). Patients must be free of disease for a minimum of 4 weeks. Partial Response: Complete disappearance of all biochemical evidence of disease in patients without a surgical procedure for a residual radiographic mass. Patients must demonstrate no biochemical recurrence or progression of radiographic masses for a minimum of four weeks (PR to chemotherapy}

Groups in this outcome

Group A

Group A: Prior Treatment Limited to \<= 6 Cycles of Cisplatin

Group B

Group B: Prior Treatment Limited to \> 6 Cycles of Cisplatin

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

Analysis denominator · Participants

GroupSource count
Group A91
Group B15

Reported measurements

Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group A50Not reportedNot reportedNot reportedNot reported
Group B4Not reportedNot reportedNot reportedNot reported
Incomplete Response (IR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group A36Not reportedNot reportedNot reportedNot reported
Group B8Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group A5Not reportedNot reportedNot reportedNot reported
Group B3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        4
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        8
    title
    Incomplete Response (IR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
    title
    Partial Response (PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      91
    2. group Id
      OG001
      value
      15
    units
    Participants
description
Overall Objective Response will be assessed prior to dose-intensive therapy and at the completion of therapy. Complete disappearance of all clinical, radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy). Patients must be free of disease for a minimum of 4 weeks. Partial Response: Complete disappearance of all biochemical evidence of disease in patients without a surgical procedure for a residual radiographic mass. Patients must demonstrate no biochemical recurrence or progression of radiographic masses for a minimum of four weeks (PR to chemotherapy}
groups
  1. description
    Group A: Prior Treatment Limited to \<= 6 Cycles of Cisplatin
    id
    OG000
    title
    Group A
  2. description
    Group B: Prior Treatment Limited to \> 6 Cycles of Cisplatin
    id
    OG001
    title
    Group B
param Type
NUMBER
reporting Status
POSTED
time Frame
2 years
title
Overall Objective Response
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice