Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients

NCT ID: NCT00693173

Last Updated: 2013-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-06-30

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.

Conditions

Anal Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grant R. Seeger, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Medical Branch at Galveston

Locations

The University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Countries

United States

Other Identifiers

07-049

Identifier Type: -

Identifier Source: org_study_id