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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.


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Breast Cancer, Gastrointestinal, Lymphomatous Malignancies

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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).


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

Stefan Both, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

UPCC 13910

NCT ID:

NCT01386697

Start Date:

November 2010

Completion Date:

June 2013

Related Keywords:

  • Lung Cancer
  • Breast Cancer
  • Gastrointestinal
  • Lymphomatous Malignancies
  • Breast Neoplasms
  • Neoplasms
  • Lung Neoplasms
  • Lymphoma

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283