Participant flow

Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers · Source last updated 2026-08-21

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

groups

1. description

   Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV External Beam Radiation Therapy: Undergo EBRT Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT

   id

   FG000

   title

   Arm I (Cisplatin, IMRT or RT, Brachytherapy)

2. description

   Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT Triapine: Given IV

   id

   FG001

   title

   Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         20

      type

      eligible and never treated

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      too early for evaluation of treatment and toxicity

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      ineligible and treated

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      ineligible and never treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         225

      2. group Id

         FG001

         num Subjects

         225

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         207

      2. group Id

         FG001

         num Subjects

         202

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         23

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

NRG-GY006 opened to accrual on January 15, 2016, and closed to accrual on September 22, 2022.

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Preserved source evidence · Not medical advice