Status:
COMPLETED
Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Anal Cancer
Eligibility:
MALE
18-80 years
Brief Summary
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 facu...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically proven anal cancer (squamous, basaloid, or cloacogenic carcinoma) or distal rectal cancer (adenocarcinoma variants) that traverse the dentate line and are eligible for definitive chemoradiation or preoperative radiation therapy, respectively.
- Any histological grade.
- Age: \>18 years.
- Gender: Male patients with average external genitalia.
- Race: Any.
- Language: English speaking only.
- Performance status: Good (Karnofsky Performance Status of \>60%). (ECOG 0-2).
- UTMB patients
- Stages: Early local disease to locoregionally advanced disease per the 2002 American Joint Committee on Cancer (AJCC) Staging System.
- Anal Cancer: Stages I-IIIB (see Section 11).
- Distal Rectal Cancers that pass the dentate line and into the anal canal only: Stages IIA-IIIC (see Section 11).
- Exclusion Criteria
- Histological variants other than those listed above in 4.a.
- Patients with cystocele or abnormal scrotal edema will be excluded. (Although the Genital Drop Technique may specifically benefit this group of patients, however this study is to be performed with average patient anatomy).
- 2002 American Joint Committee on Cancer (AJCC) Staging System. (Anal Cancer: Stage IV.; Distal Rectal Cancer: Stage IV, and tumor 2-node 0-metastasis 0 (T1-T2N0M0) patients).
- Performance status: Poor (Karnofsky Performance Status of \<60%). (ECOG 3-4).
- Non-English speaking patients.
- Prior pelvic radiation.
- Prior pelvic malignancy.
- Anal cancer/rectal cancer surgery, except for biopsy at study site.
- Patient's mental condition and social support is such that he can neither understand the nature of the protocol nor comply with its requirements.
Exclusion
Key Trial Info
Start Date :
July 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00693173
Start Date
July 1 2007
End Date
June 1 2009
Last Update
February 12 2013
Active Locations (1)
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1
The University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77550