Breast Cancer Clinical Trial
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.
NCT number | NCT01386697 |
Other study ID # | UPCC 13910 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2010 |
Est. completion date | June 2013 |
Verified date | March 2020 |
Source | Abramson Cancer Center of the University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center of the University of Pennsylvania |
United States,
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