Epidermal Growth Factor Receptor and K-ras Mutations in Patients With Stage III Non-Small Cell Lung Cancer

NCT00898924 | Completed

• 3 other identifiers: CALGB-150508U10CA031946CDR0000491128
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Up to 3 years

• Progression free survival

  Up to 3 years

Study Arms (1)

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.

Genetic: molecular diagnostic method; Genetic: mutation analysis

Interventions

molecular diagnostic method GENETIC

Group 1

mutation analysis GENETIC

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with stage III non-small cell lung cancer.

You may qualify if:

• 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

You may not qualify if:

• \. Patients with scalene, supraclavicular, or contralateral hilar lymph node involvement, or direct invasion of the vertebral body or with a pleural effusion were ineligible.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

tissue, whole blood and serum samples

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Molecular Diagnostic Techniques

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques

Study Officials

• Pasi Janne, MD, PhD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: November 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: July 1, 2010
• Last Updated: June 29, 2016

Record last verified: 2016-06