Skip to content
← Full study record

NCT00432094 · OUTCOME

Disease-free Survival (DFS)

Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors · Source last updated 2022-05-17

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

Measure
MEAN
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
1 Year

What was measured

The number of patients who survive without any signs of symptions of that cancer or any other cancer.

Analysis population: The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups.

Groups in this outcome

2 Transplants

Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. carboplatin: Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes etoposide: 600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3. thiotepa: 150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4 autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.

1 Transplant

Patients with Germ cell tumors who receive one transplant only. ifosfamide: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. paclitaxel: 225 mg/m\^2 intravenous over 3 hours on Day -7. autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) Mesna: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.

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

Analysis denominator · Participants

GroupSource count
2 Transplants14
1 Transplant9

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
2 Transplants64Not reported3483Not reported
1 Transplant44Not reported1472Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34
        upper Limit
        83
        value
        64
      2. group Id
        OG001
        lower Limit
        14
        upper Limit
        72
        value
        44
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      9
    units
    Participants
description
The number of patients who survive without any signs of symptions of that cancer or any other cancer.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. carboplatin: Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes etoposide: 600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3. thiotepa: 150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4 autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
    id
    OG000
    title
    2 Transplants
  2. description
    Patients with Germ cell tumors who receive one transplant only. ifosfamide: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. paclitaxel: 225 mg/m\^2 intravenous over 3 hours on Day -7. autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) Mesna: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
    id
    OG001
    title
    1 Transplant
param Type
MEAN
population Description
The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups.
reporting Status
POSTED
time Frame
1 Year
title
Disease-free Survival (DFS)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice