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NCT00346164 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      222
    2. group Id
      BG001
      value
      21
    3. group Id
      BG002
      value
      122
    4. group Id
      BG003
      value
      223
    5. group Id
      BG004
      value
      588
    units
    Participants
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
    BG000
    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
    BG001
    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
    BG002
    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
    BG003
    title
    Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          60.88
          value
          138.87
        2. group Id
          BG001
          spread
          59.46
          value
          142.58
        3. group Id
          BG002
          spread
          69.20
          value
          155.14
        4. group Id
          BG003
          spread
          68.90
          value
          171.31
        5. group Id
          BG004
          spread
          67.10
          value
          154.68
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Months
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          124
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          60
        4. group Id
          BG003
          value
          120
        5. group Id
          BG004
          value
          313
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          98
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          103
        5. group Id
          BG004
          value
          275
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          38
        5. group Id
          BG004
          value
          90
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          185
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          95
        4. group Id
          BG003
          value
          178
        5. group Id
          BG004
          value
          477
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          21
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          6
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          18
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          89
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          169
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          90
        4. group Id
          BG003
          value
          137
        5. group Id
          BG004
          value
          412
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          31
        5. group Id
          BG004
          value
          62
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      222
    2. group Id
      BG001
      value
      21
    3. group Id
      BG002
      value
      122
    4. group Id
      BG003
      value
      223
    5. group Id
      BG004
      value
      588
    units
    Participants
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
    BG000
    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
    BG001
    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
    BG002
    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
    BG003
    title
    Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          60.88
          value
          138.87
        2. group Id
          BG001
          spread
          59.46
          value
          142.58
        3. group Id
          BG002
          spread
          69.20
          value
          155.14
        4. group Id
          BG003
          spread
          68.90
          value
          171.31
        5. group Id
          BG004
          spread
          67.10
          value
          154.68
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Months
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          124
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          60
        4. group Id
          BG003
          value
          120
        5. group Id
          BG004
          value
          313
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          98
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          103
        5. group Id
          BG004
          value
          275
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          38
        5. group Id
          BG004
          value
          90
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          185
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          95
        4. group Id
          BG003
          value
          178
        5. group Id
          BG004
          value
          477
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          21
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          6
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          18
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          89
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          169
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          90
        4. group Id
          BG003
          value
          137
        5. group Id
          BG004
          value
          412
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          31
        5. group Id
          BG004
          value
          62
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice