Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer

Emory University

Status: Enrolling

Conditions: Small-cell Lung Cancer

Treatments: Radiation: Proton-beam Therapy for Small Cell Lung Cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT04342429

IRB00110109

Details and patient eligibility

About

To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)

Full description

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).

• To determine the rate of cardiac toxicities from IMPT in patients with small cell lung cancer compared with historical controls receiving photon-based treatment.
• To determine the rate of pneumonitis and esophagitis from IMPT and compare with historical controls receiving photon based treatment.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pathologically confirmed small cell lung cancer, limited or extensive stage.
• Patients who are offered thoracic radiotherapy with intensity-modulated proton therapy (IMPT) techniques delivering 30-66 Gy in 15-33 fractions at 2 Gy per fraction, at the recommendation of the treating radiation oncologist.
• Age 18 or greater

Exclusion criteria

• Prior radiation therapy which would provide significant dose overlap with the planned target volume(s)
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Prospective Study of Intensity-Modulated Proton Therapy (IMPT)

Experimental group

Description:

This is the first prospective study to investigate the safety and efficacy of IMPT for the treatment of SCLC. We will utilize adaptive planning throughout the radiation course. In addition, we will study the dosimetric parameters of IMPT and their correlation with treatment-related toxicities, particularly cardiac events.

Treatment:

Radiation: Proton-beam Therapy for Small Cell Lung Cancer