TriangleNCT00446225 · OUTCOME
Molecular Markers Related to EGFR and Study Pathology
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_UNITS
- Unit
- Sample of serum
- Interval / dispersion
- Not reported
- Time frame
- At baseline
What was measured
The study of mutations in serum (serum DNA). This exploratory analysis was performed to determine whether EGFR mutations can reliably be detected in serum thereby reducing the requirement for invasive techniques as well as to enable detection of mutations in patients where no tumor biopsy samples are available.
Analysis population: Intention to treat. Serum sample taken at baseline
Groups in this outcome
A: Erlotinib Group
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
B: Standard Chemotherapy Group
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.
| Group | Source count |
|---|---|
| A: Erlotinib Group | 86 |
| B: Standard Chemotherapy Group | 87 |
| Group | Source count |
|---|---|
| A: Erlotinib Group | 86 |
| B: Standard Chemotherapy Group | 87 |
Reported measurements
Mutated
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A: Erlotinib Group | 30 | Not reported | Not reported | Not reported | Not reported |
| B: Standard Chemotherapy Group | 29 | Not reported | Not reported | Not reported | Not reported |
Wild type
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A: Erlotinib Group | 24 | Not reported | Not reported | Not reported | Not reported |
| B: Standard Chemotherapy Group | 23 | Not reported | Not reported | Not reported | Not reported |
Not enough sample
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A: Erlotinib Group | 32 | Not reported | Not reported | Not reported | Not reported |
| B: Standard Chemotherapy Group | 35 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 29
- title
- Mutated
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 23
- title
- Wild type
- categories
- measurements
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 35
- title
- Not enough sample
- denom Units Selected
- Sample of serum
- denoms
- counts
- group Id
- OG000
- value
- 86
- group Id
- OG001
- value
- 87
- units
- Participants
- counts
- group Id
- OG000
- value
- 86
- group Id
- OG001
- value
- 87
- units
- Sample of serum
- description
- The study of mutations in serum (serum DNA). This exploratory analysis was performed to determine whether EGFR mutations can reliably be detected in serum thereby reducing the requirement for invasive techniques as well as to enable detection of mutations in patients where no tumor biopsy samples are available.
- 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
- OG000
- 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
- OG001
- title
- B: Standard Chemotherapy Group
- param Type
- COUNT_OF_UNITS
- population Description
- Intention to treat. Serum sample taken at baseline
- reporting Status
- POSTED
- time Frame
- At baseline
- title
- Molecular Markers Related to EGFR and Study Pathology
- type
- SECONDARY
- type Units Analyzed
- Sample of serum
- unit Of Measure
- Sample of serum
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice