Participant flow

Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma · Source last updated 2023-01-31

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

groups

1. description

   Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4. Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies

   id

   FG000

   title

   Vincristine, Dactinomycin, Cyclophosphamide (VAC)

2. description

   Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.

   id

   FG001

   title

   VAC Alternating With Vincristine, Irinotecan (VI)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         13

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         16

      type

      Ineligible

   5. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         22

      type

      Disease progression or relapse

   6. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         8

      type

      Refusal of further therapy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         239

      2. group Id

         FG001

         num Subjects

         242

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         187

      2. group Id

         FG001

         num Subjects

         181

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         52

      2. group Id

         FG001

         num Subjects

         61

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

481 excludes 33 ineligible cases (declared by the Study Chair) .

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

Preserved source evidence · Not medical advice