Intensity-Modulated Proton Therapy in Treating Patients with Limited Stage or Extensive Stage Small Cell Lung Cancer
18 Years and older, Male and Female
RAD4649-19 (primary)
NCI-2019-02577
Summary
This clinical trial studies the side effects of intensity-modulated proton therapy in treating patients with limited stage or extensive stage small cell lung cancer. Radiation therapy such as intensity-modulated proton therapy uses high energy protons to kill tumor cells and shrink tumors. Intensity-modulated proton therapy may be able to precisely target the tumor and reduce the damage to nearby healthy tissue.
Objectives
PRIMARY OBJECTIVE:
I. To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC).
SECONDARY OBJECTIVES:
I. To determine the optimal schedule for three-dimensional verification imaging and necessary re-planning of patients undergoing IMPT for a rapidly changing tumor (small cell lung cancer).
II. To determine the rate of cardiac toxicities from IMPT in patients with small cell lung cancer compared with historical controls receiving photon-based treatment.
III. To determine the rate of pneumonitis and esophagitis from IMPT and compare with historical controls receiving photon based treatment.
OUTLINE:
Beginning no later than 6 weeks after last cycle of chemotherapy, patients undergo IMPT. Patients undergo positron emission tomography (PET)-computed tomography (CT) scan, magnetic resonance imaging (MRI), and biopsy during screening and CT scan throughout the study.
After completion of study treatment, patients are followed up at 4 weeks, 3 and 6 months, 1 year, and then every 6 months for up to 5 years.
Eligibility
- Pathologically confirmed small cell lung cancer, limited or extensive stage
- Patients who are offered thoracic radiotherapy with intensity-modulated proton therapy (IMPT) techniques delivering ranging from 30-66 Gy, at the recommendation of the treating radiation oncologist
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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