Participant flow

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma · Source last updated 2023-06-29

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

groups

1. description

   Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy. Doxorubicin: given IV Bleomycin: given IV Vinblastine: given IV Dacarbazine: given IV Radiotherapy

   id

   FG000

   title

   Arm A (ABVD)

2. description

   Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide \[375 mg/m²\] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy. Doxorubicin: given IV Bleomycin: given IV Vinblastine: given IV Vincristine: given IV Mechlorethamine: given IV Etoposide: given IV Prednisone: taken orally Cyclophosphamide: given IV Radiotherapy

   id

   FG001

   title

   Arm B (Stanford V)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         1

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         2

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         5

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Alternative therapy

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Complicating disease

   7. reasons

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         21

      type

      Off-treatment reason missing

   8. reasons

      1. group Id

         FG000

         num Subjects

         33

      2. group Id

         FG001

         num Subjects

         27

      type

      Ineligible

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         428

      2. group Id

         FG001

         num Subjects

         426

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         414

      2. group Id

         FG001

         num Subjects

         422

      type

      Treated Pts w/ Toxicity Data Available

   3. achievements

      1. group Id

         FG000

         num Subjects

         395

      2. group Id

         FG001

         num Subjects

         399

      type

      Eligible Patients

   4. achievements

      1. group Id

         FG000

         num Subjects

         330

      2. group Id

         FG001

         num Subjects

         366

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         98

      2. group Id

         FG001

         num Subjects

         60

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Between April 22, 1999 and June 15, 2006, 854 participants were enrolled. The first patient accrued was on June 17, 1999.

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Preserved source evidence · Not medical advice