Clinical trial NCT00693173: Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients
Official title: Genital Drop Technique With Intensity-Modulated Radiation Therapy (IMRT) in Male Anal and Distal Rectal Cancer Patients: A Dosimetric Comparison
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal Cancer
Keywords: anal
cancer
rectal
IMRT
genital
sparing
drop
technique
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male anal cancer and distal rectal cancer patients 18 years or older.

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Genital Drop Technique (IMRT-GD) decreased the radiation dose to the testicles scrotal skin and penile shaft compared to standard prone technique.
timeFrame: Day 1. Pretreatment analysis.
Secondary outcomes:
measure: Dosimetry comparison details.
timeFrame: Day 1. Pretreatment parameters.
Other outcomes:
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch at Galveston
state: Texas
Study officials:
affiliation: The University of Texas Medical Branch at Galveston
name: Grant R. Seeger, MD
role: PRINCIPAL_INVESTIGATOR
References: