Participant flow

Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma · Source last updated 2021-07-06

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

groups

1. description

   2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.

   id

   FG000

   title

   Group 2 (Chemotherapy, Surgery)

2. description

   4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.

   id

   FG001

   title

   Group 3 (Chemotherapy, Surgery)

3. description

   8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.

   id

   FG002

   title

   Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)

4. description

   The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531. Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished.

   id

   FG003

   title

   Non-intermediate Risk Enrolled on Intermediate Risk Trial

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         1

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         19

      4. group Id

         FG003

         num Subjects

         0

      type

      Lack of Efficacy

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         16

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         0

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         15

      type

      Ineligible

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         41

      type

      Not evaluable

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         0

      type

      Patient/Parent Refusal

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         176

      2. group Id

         FG001

         num Subjects

         142

      3. group Id

         FG002

         num Subjects

         89

      4. group Id

         FG003

         num Subjects

         57

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         161

      2. group Id

         FG001

         num Subjects

         114

      3. group Id

         FG002

         num Subjects

         53

      4. group Id

         FG003

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         28

      3. group Id

         FG002

         num Subjects

         36

      4. group Id

         FG003

         num Subjects

         57

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice