Participant flow

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma · Source last updated 2022-04-28

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

groups

1. description

   Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only). clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery

   id

   FG000

   title

   Arm A: No Adjuvant Treatment

2. description

   Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy. clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery 3-dimensional conformal radiation therapy: Patients undergo radiotherapy

   id

   FG001

   title

   Arm B: Low Risk; Adjuvant Radiotherapy

3. description

   High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. doxorubicin hydrochloride: Given IV clinical observation: Patients undergo observation 3-dimensional conformal radiation therapy: Patients undergo radiotherapy ifosfamide: Given IV

   id

   FG002

   title

   Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy

4. description

   High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13. doxorubicin hydrochloride: Given IV clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery 3-dimensional conformal radiation therapy: Patients undergo radiotherapy ifosfamide: Given IV

   id

   FG003

   title

   Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy

periods

1. drop Withdraws

   1. 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

         1

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         25

      type

      Lack of Efficacy

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         27

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         4

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         23

      type

      Ineligible

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         15

      type

      Refusal of further protocol therapy

   8. 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

         11

      type

      Inability to start week 16 tx on time

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         222

      2. group Id

         FG001

         num Subjects

         21

      3. group Id

         FG002

         num Subjects

         122

      4. group Id

         FG003

         num Subjects

         223

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         205

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         96

      4. group Id

         FG003

         num Subjects

         117

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         26

      4. group Id

         FG003

         num Subjects

         106

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice