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About
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying the side effects of giving cetuximab together with cisplatin and docetaxel before radiation therapy and cetuximab followed by surgery and to see how well it works in treating patients with stage IIIB non-small cell lung cancer that can be removed by surgery.
Full description
OBJECTIVES:
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed every 3 months for 2 years and every 6 months for 3 years.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC)
Squamous, adeno, large cell, or poorly differentiated disease
Stage IIIB disease (T4N0-3M0 or T1-4N3M0) according to 6th TNM classification
Lymph node staging done by mediastinoscopy (or EBUS) in N+ disease on PET-CT scan (SUV above mediastinum background SUV) or CT (size > 10 mm in the smallest diameter) within 42 days of registration
Measurable disease assessed by contrast-enhanced CT-scan within 28 days of registration
Tumor tissue available for translational research (no cytology)
Resectable disease based on a multidisciplinary tumor board decision
No brain metastasis (confirmed by MRI within 42 days of registration)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
Masking
69 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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