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

NCT00693173 | Completed

• 1 other identifier: 07-049
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Cancer

Keywords

anal; cancer; rectal; IMRT; genital; sparing; drop; technique

Outcome Measures

Primary Outcomes (1)

• The Genital Drop Technique (IMRT-GD) decreased the radiation dose to the testicles scrotal skin and penile shaft compared to standard prone technique.

  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.

  Day 1. Pretreatment analysis.

Secondary Outcomes (1)

• Dosimetry comparison details.

  Day 1. Pretreatment parameters.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male anal cancer and distal rectal cancer patients 18 years or older.

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

The University of Texas Medical Branch at Galveston

Galveston, Texas, 77550, United States

Location

MeSH Terms

Conditions

Anus Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Study Officials

• Grant R. Seeger, MD

  The University of Texas Medical Branch at Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: July 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 12, 2013

Record last verified: 2013-02

Locations

US (1)