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NCT00047320 · OUTCOME

Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity

Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors · Source last updated 2018-02-14

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

Measure
NUMBER
Unit
participants
Interval / dispersion
95% Confidence Interval
Time frame
During chemotherapy(up to 18 weeks)

What was measured

The number of patients who experienced non-hematological grade 4 toxicities anytime during chemotherapy.

Analysis population: A total of 102 eligible patients treated with induction chemotherapy were included.

Groups in this outcome

Radiation Therapy (CR From Induction)

Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. carboplatin: Given IV etoposide: Given IV ifosfamide: Given IV thiotepa: Given IV adjuvant therapy conventional surgery neoadjuvant therapy peripheral blood stem cell transplantation radiation therapy: craniospinal irradiation

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

Analysis denominator · Participants

GroupSource count
Radiation Therapy (CR From Induction)102

Reported measurements

Source class 1
Values in participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Radiation Therapy (CR From Induction)22Not reported1431Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14
        upper Limit
        31
        value
        22
denoms
  1. counts
    1. group Id
      OG000
      value
      102
    units
    Participants
description
The number of patients who experienced non-hematological grade 4 toxicities anytime during chemotherapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. carboplatin: Given IV etoposide: Given IV ifosfamide: Given IV thiotepa: Given IV adjuvant therapy conventional surgery neoadjuvant therapy peripheral blood stem cell transplantation radiation therapy: craniospinal irradiation
    id
    OG000
    title
    Radiation Therapy (CR From Induction)
param Type
NUMBER
population Description
A total of 102 eligible patients treated with induction chemotherapy were included.
reporting Status
POSTED
time Frame
During chemotherapy(up to 18 weeks)
title
Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice