Lung Cancer RTOG-1306

May 09, 2017

Sponsor: National Cancer Institute (NCI)

Number: RTOG-1306

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase II trial (Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety) 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. Chemotherapy drugs such as Cisplatin, Etoposide, Paclitaxel, and Carboplatin, work in different ways to stop the growth of tumor cells. The chemotherapydrugs stop the growth by 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 chemo-radiation therapy in treating patients with non-small cell lung cancer.

Who’s eligible:

• Patients must have histological (tissue microscopically examined) or cytological (fluid cells microscopically examined) confirmed, newly diagnosed non-squamous NSCLC (non-small cell lung cancer).
• The patient must have unresectable (unable to be removed with surgery) stage IIIA or IIIB disease; patients must be surgically staged to confirm N2 or N3 disease(Click here for lung cancer staging definitions)
• Patients may have invasive mediastinal staging by mediastinoscopy, mediastinotomy, endobronchial ultrasound transbronchial aspiration (EBUS-TBNA), endoscopic ultrasound (EUS), or video-assisted thoracoscopic surgery (VATS).
• Patients with any tumor (T) with lymph node (N)2 or N3 are eligible; patients with T3, N1-N3 disease are eligible if deemed unresectable. Patients with T4, any N are eligible.
• Patients must have measurable disease, i.e., lesions that can be accurately measured in at least 1 dimension (longest dimension in the plane of measurement is to be recorded) with a minimum size of 10 mm by computed tomography (CT) scan (CT scan slice thickness no greater than 5 mm).
• This study is for patients age 18 and older.

Available at: The Hospital of Central Connecticut, Backus Hospital, and Hartford Hospital.