Lung CancerNCT00898924
Epidermal Growth Factor Receptor and K-ras Mutations in Patients With Stage III Non-Small Cell Lung Cancer
An observational study of Lung Cancer, run by Alliance for Clinical Trials in Oncology.
Trial summary
RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- molecular diagnostic method and mutation analysis
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with stage III non-small cell lung cancer.
Who may be able to join
- Eligible patients had histologic documentation of un- treated stage III NSCLC.
- Radiation oncologist confirmation was required that radiation could be given per protocol.
- Eastern Cooperative Group Criteria Performance Status of 0 to 2
- Tumor specimen paraffin block or unstained slides and standard initial laboratory tests
- Signed institutional review board-approved, protocol-specific in- formed consent in accordance with federal and institutional guidelines
Who cannot join
- 1. Patients with scalene, supraclavicular, or contralateral hilar lymph node involvement, or direct invasion of the vertebral body or with a pleural effusion were ineligible.
About this study
Official title: Evaluation of EGFR and K-ras Mutations in Patients With Stage III NSCLC Treated on CALGB 30106
RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations and k-ras oncogene mutations in patients with stage III non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Determine the frequency of epidermal growth factor receptor (EGFR) and K-ras mutations in patients with stage III non-small cell lung cancer (NSCLC) treated on CALGB 30106.
- Correlate presence or absence of EGFR and/or K-ras mutations with radiographic response to treatment in these patients.
OUTLINE: Tissue samples are analyzed for epidermal growth factor receptor and K-ras mutations.
- Conditions
- Lung Cancer
- Being tested
- molecular diagnostic method, mutation analysis
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molecular diagnostic methodGenetic
mutation analysisGenetic
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Tissue samples were collected from patients on Day 1, Cycle 1. Whole blood and serum samples were collected on Day 1 (Cycle 1), Day 1 (Cycle 3), post-radiotherapy ZD1839 and at progression. Receives: Genetic: molecular diagnostic method; Genetic: mutation analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Up to 3 years
Progression free survival
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startNov 2005
- Primary completionMar 2006
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Pasi Janne, MD, PhD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898924
- Sponsor's protocol ID
- CALGB-150508
- Other IDs
- U10CA031946, CALGB-150508, CDR0000491128
- Status last verified
- Jun 2016
- First submitted
- 9 May 2009
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of EGFR and K-ras Mutations in Patients With Stage III NSCLC Treated on CALGB 30106
- ClinicalTrials.gov ID
- NCT00898924
- Acronym / sponsor ID
- CALGB-150508
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations and k-ras oncogene mutations in patients with stage III non-small cell lung cancer.
Detailed description
OBJECTIVES:
- Determine the frequency of epidermal growth factor receptor (EGFR) and K-ras mutations in patients with stage III non-small cell lung cancer (NSCLC) treated on CALGB 30106.
- Correlate presence or absence of EGFR and/or K-ras mutations with radiographic response to treatment in these patients.
OUTLINE: Tissue samples are analyzed for epidermal growth factor receptor and K-ras mutations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: molecular diagnostic method, Genetic: mutation analysisTissue samples were collected from patients on Day 1, Cycle 1. Whole blood and serum samples were collected on Day 1 (Cycle 1), Day 1 (Cycle 3), post-radiotherapy ZD1839 and at progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with stage III non-small cell lung cancer.
Key inclusion criteria (5 listed)
- Eligible patients had histologic documentation of un- treated stage III NSCLC.
- Radiation oncologist confirmation was required that radiation could be given per protocol.
- Eastern Cooperative Group Criteria Performance Status of 0 to 2
- Tumor specimen paraffin block or unstained slides and standard initial laboratory tests
- Signed institutional review board-approved, protocol-specific in- formed consent in accordance with federal and institutional guidelines
Key exclusion criteria (1 listed)
- 1. Patients with scalene, supraclavicular, or contralateral hilar lymph node involvement, or direct invasion of the vertebral body or with a pleural effusion were ineligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| molecular diagnostic method | Genetic | Group 1 |
| mutation analysis | Genetic | Group 1 |
Primary outcome
Overall survival
Time frame: Up to 3 years
Progression free survival
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasi Janne, MD, PhD study chair
Dana-Farber Cancer Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Alliance for Clinical Trials in Oncology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.