Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00693173|
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : February 12, 2013
|Condition or disease|
This is a study of two different setups when treating a patient with standard of care radiation doses. The study compares two patient setups (Standard Prone vs. Genital Drop Technique) with identical radiation treatment technique and parameters. After the two setups have been planned, the treating faculty reviews the setups and will choose the setup he feels that will give the patient improved dosimetry to the local regions and hopefully reduce toxicity and improve treatment tolerability.
Patients will not be randomized or stratified by demographic or disease risk assessment, but treatment will be tailored to stage specific current standards of care.
An extra (non standard of care) CT is required to analyze the data.
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Official Title:||Genital Drop Technique With Intensity-Modulated Radiation Therapy (IMRT) in Male Anal and Distal Rectal Cancer Patients: A Dosimetric Comparison|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
- The Genital Drop Technique (IMRT-GD) decreased the radiation dose to the testicles scrotal skin and penile shaft compared to standard prone technique. [ Time Frame: Day 1. Pretreatment analysis. ]The Genital Drop Technique (IMRT-GD) decreased the radiation dose to the testicles, scrotal skin and penile shaft compared to the standard conformal radiation therapy (CRT) and IMRT plans while preserving adequate planned target volume (PTV) dose coverage and homogeneity to the target organs in male anal cancer patients.
- Dosimetry comparison details. [ Time Frame: Day 1. Pretreatment parameters. ]
Testicular dose: Volume receiving 14 Gy was 90% with CRT, 64% with IMRT, and 3% with IMRT-GD.
Testicular dose: Volume receiving 30 Gy was 54% with CRT, 26% with IMRT, and 0% with IMRT-GD.
External genitalia dose: Volume receiving 14 Gy was 93% with CRT, 79% with IMRT, and 35% with IMRT-GD.
External genitalia dose: Volume receiving 30 Gy was 75% with CRT, 31% with IMRT, and 12% with IMRT-GD.
Planning Target Volume receiving full 54 Gy dose was 93% with CRT, 93% with IMRT, and 94% with IMRT-GD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693173
|United States, Texas|
|The University of Texas Medical Branch at Galveston|
|Galveston, Texas, United States, 77550|
|Principal Investigator:||Grant R. Seeger, MD||The University of Texas Medical Branch at Galveston|