DIBH Proton Planning

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT01386697
Collaborator
(none)
40
1
31
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Study Details

Study Description

Brief Summary

The overall objective is to estimate the actual or potential benefit of deep inspiration breath holding (DIBH) treatment in the context of proton radiotherapy as compared to 3 dimensional conformal radiation therapy (3DCRT) and intensity-modulated x-ray therapy (IMXT), as it relates to variability in tumor localization, treatment margins, target volume definition, doses to organs at risk and variations with treatment planning.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    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.
    Study Start Date :
    Nov 1, 2010
    Actual Primary Completion Date :
    Jun 1, 2013
    Actual Study Completion Date :
    Jun 1, 2013

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Age 18 and older

      • Biopsy-proven malignancy

      • The diagnosis of hepatocellular carcinoma may be made on a clinical basis without the need for a biopsy if the following criteria are met: a) Documentation of hepatitis B or C infection b)Liver mass with characteristic imaging (CT or MRI) features of hepatocellular carcinoma c) Alpha-feta protein (AFP) level greater than 20 ng/mL 3. Planned curative external beam RT as part of the patients treatment for the cancer diagnosis.

      • Subject must be cable of giving informed consent for standard external beam radiation therapy as well as for the study.

      • Subjects must be able to tolerate the deep inspiration breath hold (DIBH) training and procedures.

      Exclusion Criteria:
      • Subjects unsuitable for or unable to undergo definitive external beam, radiation therapy for their diagnosis of cancer

      • Subjects undergoing radiation with palliative (i.e., non-curative) intent.

      • Subjects unwilling to undergo simulation with the SpiroDynrX (SDX) system.

      • Subjects unable to hold their breath for a minimum of 10 seconds.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

      Sponsors and Collaborators

      • Abramson Cancer Center of the University of Pennsylvania

      Investigators

      • Principal Investigator: John Plastaras, MD, Abramson Cancer Center of the University of Pennsylvania

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Abramson Cancer Center of the University of Pennsylvania
      ClinicalTrials.gov Identifier:
      NCT01386697
      Other Study ID Numbers:
      • UPCC 13910
      First Posted:
      Jul 1, 2011
      Last Update Posted:
      Mar 10, 2020
      Last Verified:
      Mar 1, 2020
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Mar 10, 2020