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NCT00047320 · OUTCOME

Response to Induction Chemotherapy

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
18 weeks

What was measured

A patient who achieves a complete or partial response, defined a reduction of at least 65% in tumor size after induction chemotherapy will be considered to have experienced response.

Analysis population: Of the 102 eligible patients, 85 completed induction chemotherapy with sufficient data to assess response. Central review response assessment is used.

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)85

Reported measurements

Responder
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Radiation Therapy (CR From Induction)74Not reportedNot reportedNot reportedNot reported
Non-Responder
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Radiation Therapy (CR From Induction)11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        74
    title
    Responder
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Non-Responder
denoms
  1. counts
    1. group Id
      OG000
      value
      85
    units
    Participants
description
A patient who achieves a complete or partial response, defined a reduction of at least 65% in tumor size after induction chemotherapy will be considered to have experienced response.
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
COUNT_OF_PARTICIPANTS
population Description
Of the 102 eligible patients, 85 completed induction chemotherapy with sufficient data to assess response. Central review response assessment is used.
reporting Status
POSTED
time Frame
18 weeks
title
Response to Induction Chemotherapy
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice