Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proton-beam Therapy for Small Cell Lung Cancer.
- Who it may be relevant to
- Registry conditions: Small-cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
RAD4649-19: Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
Overview
To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)
Detailed 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.
Interventions
- Radiation Proton-beam Therapy for Small Cell Lung Cancer
The goal of intensity-modulated proton therapy (IMPT) is to deliver radiation to the tumor while minimizing exposure to surrounding normal tissues.
Primary outcome measures
- Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT). [Time frame: Up to 1 year from study start]
- Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning [Time frame: Up to 1,2, and 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Winship Cancer Institute — Atlanta
Identifiers
NCT: NCT04342429 · IRB00110109