This clinical trial studies image-guided hypofractionated radiation therapy (RT) when given together with hypofractionated RT boost and combination chemotherapy in treating patients with stage II-III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. RT uses high energy x-rays to kill tumor cells. Hypofractionated RT may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving RT together with combination chemotherapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) using hypofractionated RT in patients with stage II-III NSCLC. SECONDARY OBJECTIVES: I. To determine the dose-limiting toxicity, if the MTD is reached. II. To determine the tumor local control (LC). III. To determine the lung cancer disease specific survival (DSS). IV. To determine the overall survival (OS). V. To assess the transforming growth factor-beta (TGF-B), interleukin (IL)-1, and IL-6 levels as predictive biomarkers for treatment induced tissue injury. OUTLINE: This is a dose-escalation study of image-guided hypofractionated RT. Patients undergo image-guided hypofractionated RT over 35 minutes 5 days a week for 2 weeks followed by 5 fractions of hypofractionated RT boost. Patients also receive standard carboplatin and paclitaxel for 3 weeks. After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for the first 2 years, and then periodically thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Undergo image-guided hypofractionated Radiation Therapy over 35 minutes 5 days a week for 2 weeks
Correlative studies
Undergo 5 fractions of image-guided hypofractionated Radiation Therapy boost.
The maximal chemotherapy treatment dose for carboplatin during the 3 week radiation therapy is AUC 2.
The maximal chemotherapy treatment dose for paclitaxel during the 3 week radiation therapy is 45mg/m2.
Undergo hypofractionated RT
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
To determine the maximal tolerated dose using hypofractionated radiotherapy in patients with stage II-III non small cell lung cancer.
The primary end point is to reach the maximum tolerated dose or a total of 75 Gy, whichever comes first, by escalating the daily dose of last 5 fractions.
Time frame: up to 90 days
To determine tumor Local control
Radiological evaluation (CT, PET-CT) will be done to assess tumor.
Time frame: participants will be followed for 2 years
To determine Lung cancer Disease specific survival
Time frame: Participants will be followed for 2 years
Overall survival
Time frame: Participants will be followed for 2 years
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