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NCT00011986 · BASELINE

Baseline characteristics

Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer · Source last updated 2019-04-16

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
      864
    2. group Id
      BG001
      value
      864
    3. group Id
      BG002
      value
      862
    4. group Id
      BG003
      value
      861
    5. group Id
      BG004
      value
      861
    6. group Id
      BG005
      value
      4312
    units
    Participants
groups
  1. description
    Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
    id
    BG000
    title
    Carbo/Taxol
  2. description
    Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
    id
    BG001
    title
    Carbo/Taxol/Gemcitabine
  3. description
    Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
    id
    BG002
    title
    Carbo/Taxol/Doxil
  4. description
    Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
    id
    BG003
    title
    Carbo/Topotecan - Carbo/Taxol
  5. description
    Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
    id
    BG004
    title
    Carbo/Gemcitabine - Carbo/Taxol
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.1
          value
          57.8
        2. group Id
          BG001
          spread
          10.8
          value
          58.8
        3. group Id
          BG002
          spread
          11.1
          value
          59.0
        4. group Id
          BG003
          spread
          11.0
          value
          58.2
        5. group Id
          BG004
          spread
          10.7
          value
          58.9
        6. group Id
          BG005
          spread
          10.9
          value
          58.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          864
        2. group Id
          BG001
          value
          864
        3. group Id
          BG002
          value
          862
        4. group Id
          BG003
          value
          861
        5. group Id
          BG004
          value
          861
        6. group Id
          BG005
          value
          4312
        title
        Female
      2. 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
        6. group Id
          BG005
          value
          0
        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
          724
        2. group Id
          BG001
          value
          749
        3. group Id
          BG002
          value
          743
        4. group Id
          BG003
          value
          744
        5. group Id
          BG004
          value
          721
        6. group Id
          BG005
          value
          3681
      title
      Stage III:see description for details
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          140
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          119
        4. group Id
          BG003
          value
          117
        5. group Id
          BG004
          value
          140
        6. group Id
          BG005
          value
          631
      title
      Stage IV:see description for details
    description
    FIGO Staging Classification: 1985. Stage III: Tumor involving one or both ovaries with peritoneal implants outside the pelvis and/or positive retroperitoneal or inguinal nodes. Superficial liver metastasis equals Stage III. Tumor is limited to the true pelvis but with histologically verified malignant extensions to small bowel or omentum. Stage IV: Growth involving one or both ovaries with distant metastasis. If pleural effusion is present there must be positive cytologic test results to allot a case to Stage IV. Parenchymal liver metastasis equals Stage IV.
    param Type
    NUMBER
    title
    International Federation of Gynecology and Obstetrics (FIGO) Stage
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          748
        2. group Id
          BG001
          value
          752
        3. group Id
          BG002
          value
          737
        4. group Id
          BG003
          value
          752
        5. group Id
          BG004
          value
          751
        6. group Id
          BG005
          value
          3740
      title
      Ovary
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          116
        2. group Id
          BG001
          value
          112
        3. group Id
          BG002
          value
          125
        4. group Id
          BG003
          value
          109
        5. group Id
          BG004
          value
          110
        6. group Id
          BG005
          value
          572
      title
      Peritoneum
    param Type
    NUMBER
    title
    Primary Site of Disease
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          197
        2. group Id
          BG001
          value
          218
        3. group Id
          BG002
          value
          206
        4. group Id
          BG003
          value
          220
        5. group Id
          BG004
          value
          203
        6. group Id
          BG005
          value
          1044
      title
      Microscopic only
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          404
        2. group Id
          BG001
          value
          384
        3. group Id
          BG002
          value
          405
        4. group Id
          BG003
          value
          358
        5. group Id
          BG004
          value
          398
        6. group Id
          BG005
          value
          1949
      title
      ≤ 1 cm gross disease
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          263
        2. group Id
          BG001
          value
          262
        3. group Id
          BG002
          value
          251
        4. group Id
          BG003
          value
          283
        5. group Id
          BG004
          value
          260
        6. group Id
          BG005
          value
          1319
      title
      > 1 cm gross disease
    param Type
    NUMBER
    title
    Size of Residual Disease
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      864
    2. group Id
      BG001
      value
      864
    3. group Id
      BG002
      value
      862
    4. group Id
      BG003
      value
      861
    5. group Id
      BG004
      value
      861
    6. group Id
      BG005
      value
      4312
    units
    Participants
groups
  1. description
    Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
    id
    BG000
    title
    Carbo/Taxol
  2. description
    Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
    id
    BG001
    title
    Carbo/Taxol/Gemcitabine
  3. description
    Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
    id
    BG002
    title
    Carbo/Taxol/Doxil
  4. description
    Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
    id
    BG003
    title
    Carbo/Topotecan - Carbo/Taxol
  5. description
    Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
    id
    BG004
    title
    Carbo/Gemcitabine - Carbo/Taxol
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.1
          value
          57.8
        2. group Id
          BG001
          spread
          10.8
          value
          58.8
        3. group Id
          BG002
          spread
          11.1
          value
          59.0
        4. group Id
          BG003
          spread
          11.0
          value
          58.2
        5. group Id
          BG004
          spread
          10.7
          value
          58.9
        6. group Id
          BG005
          spread
          10.9
          value
          58.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          864
        2. group Id
          BG001
          value
          864
        3. group Id
          BG002
          value
          862
        4. group Id
          BG003
          value
          861
        5. group Id
          BG004
          value
          861
        6. group Id
          BG005
          value
          4312
        title
        Female
      2. 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
        6. group Id
          BG005
          value
          0
        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
          724
        2. group Id
          BG001
          value
          749
        3. group Id
          BG002
          value
          743
        4. group Id
          BG003
          value
          744
        5. group Id
          BG004
          value
          721
        6. group Id
          BG005
          value
          3681
      title
      Stage III:see description for details
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          140
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          119
        4. group Id
          BG003
          value
          117
        5. group Id
          BG004
          value
          140
        6. group Id
          BG005
          value
          631
      title
      Stage IV:see description for details
    description
    FIGO Staging Classification: 1985. Stage III: Tumor involving one or both ovaries with peritoneal implants outside the pelvis and/or positive retroperitoneal or inguinal nodes. Superficial liver metastasis equals Stage III. Tumor is limited to the true pelvis but with histologically verified malignant extensions to small bowel or omentum. Stage IV: Growth involving one or both ovaries with distant metastasis. If pleural effusion is present there must be positive cytologic test results to allot a case to Stage IV. Parenchymal liver metastasis equals Stage IV.
    param Type
    NUMBER
    title
    International Federation of Gynecology and Obstetrics (FIGO) Stage
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          748
        2. group Id
          BG001
          value
          752
        3. group Id
          BG002
          value
          737
        4. group Id
          BG003
          value
          752
        5. group Id
          BG004
          value
          751
        6. group Id
          BG005
          value
          3740
      title
      Ovary
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          116
        2. group Id
          BG001
          value
          112
        3. group Id
          BG002
          value
          125
        4. group Id
          BG003
          value
          109
        5. group Id
          BG004
          value
          110
        6. group Id
          BG005
          value
          572
      title
      Peritoneum
    param Type
    NUMBER
    title
    Primary Site of Disease
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          197
        2. group Id
          BG001
          value
          218
        3. group Id
          BG002
          value
          206
        4. group Id
          BG003
          value
          220
        5. group Id
          BG004
          value
          203
        6. group Id
          BG005
          value
          1044
      title
      Microscopic only
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          404
        2. group Id
          BG001
          value
          384
        3. group Id
          BG002
          value
          405
        4. group Id
          BG003
          value
          358
        5. group Id
          BG004
          value
          398
        6. group Id
          BG005
          value
          1949
      title
      ≤ 1 cm gross disease
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          263
        2. group Id
          BG001
          value
          262
        3. group Id
          BG002
          value
          251
        4. group Id
          BG003
          value
          283
        5. group Id
          BG004
          value
          260
        6. group Id
          BG005
          value
          1319
      title
      > 1 cm gross disease
    param Type
    NUMBER
    title
    Size of Residual Disease
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice