Participant flow

Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT · Source last updated 2015-12-24

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

groups

1. description

   Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen \[vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)\] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT. Radiation Therapy: Pts w/ M0 dz OR M+ dz aged \<3y received focal RT (3D conformal or intensity-modulated delivery). Pts \>3y w/ M+ dz rcvd craniospinal irradiation. Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.

   id

   FG000

   title

   Multi-agent Intrathecal and Systemic CT With RT (Modified IRS

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Progressive Disease

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Pt Non-Compliance

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Ineligible

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         25

      type

      STARTED

   2. achievements

      1. comment

         4 ineligible pts upon central path review (n=3) and per DFCI IRB (n=1); 1 pt withdrew before rcv trt

         group Id

         FG000

         num Subjects

         20

      type

      Eligible and Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         12

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         13

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Enrollment Sep 2004 to Sep 2006 at 9 institutions.

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Preserved source evidence · Not medical advice