NCT00446225 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 86
- group Id
- BG001
- value
- 87
- group Id
- BG002
- value
- 173
- units
- Participants
- groups
- description
- Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
- id
- BG000
- title
- A: Erlotinib Group
- description
- 4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy * 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or * 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: * 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or * 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
- id
- BG001
- title
- B: Standard Chemotherapy Group
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 53
- upper Limit
- 82
- value
- 65
- group Id
- BG001
- lower Limit
- 46
- upper Limit
- 82
- value
- 65
- group Id
- BG002
- lower Limit
- 46
- upper Limit
- 82
- value
- 65
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 58
- group Id
- BG001
- value
- 68
- group Id
- BG002
- value
- 126
- title
- Female
- measurements
- group Id
- BG000
- value
- 28
- group Id
- BG001
- value
- 19
- group Id
- BG002
- value
- 47
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 86
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 171
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 2
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 11
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 19
- title
- Italy
- categories
- measurements
- group Id
- BG000
- value
- 21
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 39
- title
- France
- categories
- measurements
- group Id
- BG000
- value
- 54
- group Id
- BG001
- value
- 61
- group Id
- BG002
- value
- 115
- title
- Spain
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 57
- group Id
- BG001
- value
- 63
- group Id
- BG002
- value
- 120
- title
- Never smoked
- categories
- measurements
- group Id
- BG000
- value
- 22
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 34
- title
- Previous smoker
- categories
- measurements
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 19
- title
- Current smoker
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Smoking status
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 27
- group Id
- BG001
- value
- 30
- group Id
- BG002
- value
- 57
- title
- ECOG 0
- categories
- measurements
- group Id
- BG000
- value
- 47
- group Id
- BG001
- value
- 45
- group Id
- BG002
- value
- 92
- title
- ECOG 1
- categories
- measurements
- group Id
- BG000
- value
- 12
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 24
- title
- ECOG 2
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- ECOG 3
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- ECOG 4
- description
- ECOG Performance Status Scale: It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability GRADES: ECOG 0: Fully active. ECOG 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature ECOG 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours ECOG 3: Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours ECOG 4: Completely disabled ECOG 5: Dead
- param Type
- COUNT_OF_PARTICIPANTS
- title
- ECOG Performance Status Scale
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 82
- group Id
- BG001
- value
- 78
- group Id
- BG002
- value
- 160
- title
- Adenocarcinoma
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 2
- title
- Bronchoalveolar adenocarcinoma
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 4
- title
- Large-cell carcinoma
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- title
- Squamous-cell carcinoma
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- title
- Pleomorphic carcinoma
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- title
- Adenosquamous carcinoma
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 4
- title
- Undifferentiated carcinomas
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Histological diagnosis
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- title
- Stage IIIA
- categories
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 11
- title
- Stage IIIB (malignant pleural effusion)
- categories
- measurements
- group Id
- BG000
- value
- 78
- group Id
- BG001
- value
- 82
- group Id
- BG002
- value
- 160
- title
- Stage IV
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- title
- Stage II C
- description
- Staging is a classification where cancer is located, if or where it has spread and whether it's affecting other parts of the body. There are 5 stages for NSCLC: Stage 0:tumor hasn't grown into nearby normal lung tissues Stage I:small tumor that hasn't spread to any lymph nodes Stage II: medium tumor that hasn't spread to the nearby lymph nodes or N1 Stage III: cancer spread to the lymph nodes but haven't spread to other distant parts of the body Stage IV:cancer has spread to more than 1 area in the other lung, the fluid surrounding the lung or the heart, or distant parts of the body
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Clinical stage
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 28
- group Id
- BG001
- value
- 29
- group Id
- BG002
- value
- 57
- title
- Yes
- categories
- measurements
- group Id
- BG000
- value
- 58
- group Id
- BG001
- value
- 58
- group Id
- BG002
- value
- 116
- title
- No
- description
- Bone metastasis in lung cancer occurs when cancer cells spread from the lungs to the bones. This happens when cancer cells break away from the primary lung tumor, travel through the bloodstream or lymphatic system, and establish new tumors in bone tissue.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Bone metastasis
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 11
- group Id
- BG002
- value
- 20
- title
- Yes
- categories
- measurements
- group Id
- BG000
- value
- 77
- group Id
- BG001
- value
- 76
- group Id
- BG002
- value
- 153
- title
- No
- description
- Brain metastasis in lung cancer occurs when cancer cells from the lungs spread to the brain. This is a common complication in advanced-stage lung cancer, particularly with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). It happens when cancer cells travel through the bloodstream or lymphatic system and invade brain tissue.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Brain metastasis
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 57
- group Id
- BG001
- value
- 58
- group Id
- BG002
- value
- 115
- title
- Deletion of exon 19
- categories
- measurements
- group Id
- BG000
- value
- 29
- group Id
- BG001
- value
- 29
- group Id
- BG002
- value
- 58
- title
- L858R mutation in exon 21
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- Other
- description
- EGFR (epidermal growth factor receptor) mutations in NSCLC types: Exon19 Deletions: It leads to the activation of EGFR contributing to cancer cell growth. Exon21 L858R Mutation: It involves a substitution of leucine for arginine and leads to receptor activation promoting tumor growth. Exon20 Insertion Mutations: Insertion of small amino acid and are often resistant to EGFR inhibitors. T790M Mutation: Associated with resistance to TKIs. Exon19-21 Complex Mutations: Across exon 19 \& 21. Testing for EGFR mutations is crucial for selecting the appropriate therapy in cancer treatment.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Type of EGFR mutation
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 86
- group Id
- BG001
- value
- 87
- group Id
- BG002
- value
- 173
- units
- Participants
- groups
- description
- Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
- id
- BG000
- title
- A: Erlotinib Group
- description
- 4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy * 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or * 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: * 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or * 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
- id
- BG001
- title
- B: Standard Chemotherapy Group
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 53
- upper Limit
- 82
- value
- 65
- group Id
- BG001
- lower Limit
- 46
- upper Limit
- 82
- value
- 65
- group Id
- BG002
- lower Limit
- 46
- upper Limit
- 82
- value
- 65
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 58
- group Id
- BG001
- value
- 68
- group Id
- BG002
- value
- 126
- title
- Female
- measurements
- group Id
- BG000
- value
- 28
- group Id
- BG001
- value
- 19
- group Id
- BG002
- value
- 47
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 86
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 171
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 2
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 11
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 19
- title
- Italy
- categories
- measurements
- group Id
- BG000
- value
- 21
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 39
- title
- France
- categories
- measurements
- group Id
- BG000
- value
- 54
- group Id
- BG001
- value
- 61
- group Id
- BG002
- value
- 115
- title
- Spain
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 57
- group Id
- BG001
- value
- 63
- group Id
- BG002
- value
- 120
- title
- Never smoked
- categories
- measurements
- group Id
- BG000
- value
- 22
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 34
- title
- Previous smoker
- categories
- measurements
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 19
- title
- Current smoker
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Smoking status
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 27
- group Id
- BG001
- value
- 30
- group Id
- BG002
- value
- 57
- title
- ECOG 0
- categories
- measurements
- group Id
- BG000
- value
- 47
- group Id
- BG001
- value
- 45
- group Id
- BG002
- value
- 92
- title
- ECOG 1
- categories
- measurements
- group Id
- BG000
- value
- 12
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 24
- title
- ECOG 2
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- ECOG 3
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- ECOG 4
- description
- ECOG Performance Status Scale: It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability GRADES: ECOG 0: Fully active. ECOG 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature ECOG 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours ECOG 3: Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours ECOG 4: Completely disabled ECOG 5: Dead
- param Type
- COUNT_OF_PARTICIPANTS
- title
- ECOG Performance Status Scale
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 82
- group Id
- BG001
- value
- 78
- group Id
- BG002
- value
- 160
- title
- Adenocarcinoma
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 2
- title
- Bronchoalveolar adenocarcinoma
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 4
- title
- Large-cell carcinoma
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- title
- Squamous-cell carcinoma
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- title
- Pleomorphic carcinoma
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- title
- Adenosquamous carcinoma
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 4
- title
- Undifferentiated carcinomas
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Histological diagnosis
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- title
- Stage IIIA
- categories
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 11
- title
- Stage IIIB (malignant pleural effusion)
- categories
- measurements
- group Id
- BG000
- value
- 78
- group Id
- BG001
- value
- 82
- group Id
- BG002
- value
- 160
- title
- Stage IV
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- title
- Stage II C
- description
- Staging is a classification where cancer is located, if or where it has spread and whether it's affecting other parts of the body. There are 5 stages for NSCLC: Stage 0:tumor hasn't grown into nearby normal lung tissues Stage I:small tumor that hasn't spread to any lymph nodes Stage II: medium tumor that hasn't spread to the nearby lymph nodes or N1 Stage III: cancer spread to the lymph nodes but haven't spread to other distant parts of the body Stage IV:cancer has spread to more than 1 area in the other lung, the fluid surrounding the lung or the heart, or distant parts of the body
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Clinical stage
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 28
- group Id
- BG001
- value
- 29
- group Id
- BG002
- value
- 57
- title
- Yes
- categories
- measurements
- group Id
- BG000
- value
- 58
- group Id
- BG001
- value
- 58
- group Id
- BG002
- value
- 116
- title
- No
- description
- Bone metastasis in lung cancer occurs when cancer cells spread from the lungs to the bones. This happens when cancer cells break away from the primary lung tumor, travel through the bloodstream or lymphatic system, and establish new tumors in bone tissue.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Bone metastasis
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 11
- group Id
- BG002
- value
- 20
- title
- Yes
- categories
- measurements
- group Id
- BG000
- value
- 77
- group Id
- BG001
- value
- 76
- group Id
- BG002
- value
- 153
- title
- No
- description
- Brain metastasis in lung cancer occurs when cancer cells from the lungs spread to the brain. This is a common complication in advanced-stage lung cancer, particularly with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). It happens when cancer cells travel through the bloodstream or lymphatic system and invade brain tissue.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Brain metastasis
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 57
- group Id
- BG001
- value
- 58
- group Id
- BG002
- value
- 115
- title
- Deletion of exon 19
- categories
- measurements
- group Id
- BG000
- value
- 29
- group Id
- BG001
- value
- 29
- group Id
- BG002
- value
- 58
- title
- L858R mutation in exon 21
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- Other
- description
- EGFR (epidermal growth factor receptor) mutations in NSCLC types: Exon19 Deletions: It leads to the activation of EGFR contributing to cancer cell growth. Exon21 L858R Mutation: It involves a substitution of leucine for arginine and leads to receptor activation promoting tumor growth. Exon20 Insertion Mutations: Insertion of small amino acid and are often resistant to EGFR inhibitors. T790M Mutation: Associated with resistance to TKIs. Exon19-21 Complex Mutations: Across exon 19 \& 21. Testing for EGFR mutations is crucial for selecting the appropriate therapy in cancer treatment.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Type of EGFR mutation
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle