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Clinical Trials (PDQ®)

DIBH Proton Planning

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedDiagnostic, TreatmentActive18 and overOtherUPCC 13910
NCT01386697

Trial Description

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.

Further Study Information

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).

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Abramson Cancer Center of the University of Pennsylvania

Stefan Both, PhDPrincipal Investigator

Stefan Both, PhDPh: 855-216-0098
  Email: PennCancerTrials@emergingmed.com

Trial Sites

U.S.A.
Pennsylvania
  Philadelphia
 Abramson Cancer Center of the University of Pennsylvania
 Stefan Both, MD Ph: 855-216-0098
  Email: PennCancerTrials@emergingmed.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01386697
ClinicalTrials.gov processed this data on September 16, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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