a study on Lung Cancer
This randomized phase II trial studies how well erlotinib hydrochloride or crizotinib with chemoradiation therapy works in treating patients with stage III non-small cell lung cancer. 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. Drugs used in chemotherapy, such as cisplatin, etoposide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving erlotinib hydrochloride is more effective than crizotinib with chemoradiation therapy in treating patients with non-small cell lung cancer.
A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC)
I. To assess whether patients with unresectable local-regionally advanced non-small cell lung cancer (NSCLC) treated with targeted agents based on molecular characteristics have a longer progression-free survival than those treated with standard care therapy alone.
I. To evaluate response rate. II. To assess toxicity. III. To assess overall survival. IV. To correlate clinical outcomes with tumor molecular aberrations identified from deep sequencing of selected kinomes in patients from whom adequate baseline tissue is available.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I (induction therapy): Patients receive erlotinib hydrochloride orally (PO) once daily (QD) for up to 12 weeks. Patients who have had no response (partial or complete) after 6 weeks undergo concurrent chemoradiation therapy immediately. After 2 weeks of completion of induction therapy, patients receive chemoradiation.
ARM III (induction therapy): Patients receive crizotinib PO twice daily (BID) for up to 12 weeks. Patients who have had no response (partial or complete) after 6 weeks undergo concurrent chemoradiation therapy immediately. After 2 weeks of completion of induction therapy, patients receive chemoradiation.
ARMS II AND IV (concurrent chemoradiation): Patients receive concurrent chemotherapy with thoracic radiation therapy beginning on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.
CHEMORADIATION: In all treatment arms, patients undergo concurrent intensity modulated radiation therapy (IMRT) or 3-dimensional conformal radiation therapy (3-D CRT) QD 5 days a week for 6 weeks. Patients receive 1 of 2 chemotherapy regimens based on the discretion of the treating physician. Patients receive cisplatin intravenously (IV) over 1-2 hours on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Some patients receive paclitaxel IV and carboplatin IV on days 1, 8, 15, 22, 29, and 36 during radiation therapy for 6 weeks. Two courses of consolidation treatment will begin 4-6 weeks after completion of radiation therapy with paclitaxel IV on days 1 and 22 and carboplatin IV on days 1 and 22 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 and 2 months, 4-6 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
Stage IIIA Non-Small Cell Lung Cancer Stage IIIB Non-Small Cell Lung Cancer Etoposide phosphate Erlotinib Hydrochloride Etoposide Carboplatin Cisplatin Podophyllotoxin Paclitaxel Crizotinib Succinylcholine
Open to people ages 18 years and up
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