Status:
COMPLETED
S0720: Adjuvant Therapy Based on Gene Expression in Stage IA and IB Non-Small Cell Lung Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Givin...
Detailed Description
OBJECTIVES: Primary * To assess the feasibility of assigning adjuvant treatment based on tumoral RRM1 and ERCC1 gene expression in patients with complete surgical resection of stage IA (≥ 2 cm) or I...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer
- Stage IA (longest tumor diameter 2-3 cm) or stage IB disease
- Must have undergone preoperative CT scan of the chest (including the entire liver and adrenals) with IV contrast AND a whole body PET scan or a combined PET/CT scan with no evidence of N1, N2, N3, or M1 disease within 42 days prior to surgery
- A whole body PET scan or a combined PET/CT must be performed within 84 days
- Any finding on PET scan that clinically suggests N1, N2, N3, or M1 disease must have been cleared by further evaluation, including, but not limited to, any of the following:
- Ultrasonography, X-ray radiology, magnetic resonance imaging, or nuclear medicine imaging
- Completely resected (R0) disease by lobectomy, bilobectomy, or pneumonectomy performed by open thoracotomy or video-assisted thoracoscopic surgery within the past 35 days
- Completely excised primary lesion with negative gross and microscopic margins
- At least two mediastinal lymph node stations sampled
- Must have tumor tissue available from the surgical resection specimen AND agree to have treatment assignment determined by a gene expression analysis performed on that tissue
- PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 mg/dL
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 1.5 times ULN
- Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I-II cancer from which the patient is currently in complete remission
- Any other cancer from which the patient has been disease-free for 5 years
- Willing to provide prior smoking history
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic chemotherapy or biologic therapy for lung cancer
- No prior thoracic radiation therapy (RT) (including RT to the chest wall)
- No other concurrent investigational agents, chemotherapeutic agents, RT, or hormonal therapy
- Steroids administered for antiemesis, adrenal failure, or septic shock OR hormones administered for non-disease-related conditions (e.g., insulin for diabetes) allowed
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00792701
Start Date
November 1 2008
End Date
April 1 2016
Last Update
March 6 2020
Active Locations (147)
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1
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72903
2
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
3
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Marysville, California, United States, 95901
4
Valley Medical Oncology Consultants - Pleasanton
Pleasanton, California, United States, 94588