Trial Information

A Prospective Radiation Oncology Planning Study For Lung, Gastrointestinal And Lymphomatous Malignancies Using Proton Radiotherapy As Compared To 3D Conformal And Intensity-Modulated X-Ray Therapy For Dosimetric Evaluation Of Tumoral Coverage And Dose To Organs-At-Risk.

Image acquisition and treatment under deep inspiration breath hold (DIBH) has been
demonstrated to reduce treated volumes and doses to organs at risk (OARs) for photon
radiotherapy but has not been investigated in the context of proton radiotherapy. The
objective of this registry study is to prospectively evaluate deep inspiration breath hold
CT scans for use in proton radiotherapy treatment planning and obtain dosimetric data to
assess for changes in target volume, planning volumes and doses both to tumor and organs at
risk using the SpiroDynrX (SDX) deep inspiration breath hold system as compared to free
breathing and 4D CT scans. Patients will be treated with photon therapy. This is a
prospective non-randomized, single arm, single institution registry study of patients
undergoing definitive external beam photon radiotherapy in our department. Deep inspiration
breath hold CT scans will be obtained in our department in the treatment position at the
time of CT simulationin addition to the currently obtained free breathing and 4D CT scans.
These scans will all be co-registered with the treatment planning CT. Treatment planning
volumes will be delineated by the physician and compared to the results and data for our
current standard of care utilizing 4D CT scans. Patients will be treated with breath hold
CT using photon radiotherapy but we will prospectively create proton treatment plans which
will also be compared to the photon treatment plans used for actual treatment. Variability
in tumor localization, target volume definition, doses to organs at risk and treatment
planning particularities will be summarized and reported across several modalities,
including: 3 dimensional conformal radiation therapy (3DCRT), intensity-modulated x-ray
therapy (IMXT) and proton therapy. Correlations will be statistically analyzed and reported
in terms of minimum, maximum, average and standard deviation, and other dose volume
histogram parameters, and where appropriate, compared with appropriate statistical methods
(for example, student t-test).