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Genital Drop Technique With Intensity-Modulated Radiation Therapy (IMRT) in Male Anal and Distal Rectal Cancer Patients: A Dosimetric Comparison


N/A
18 Years
80 Years
Not Enrolling
Male
Anal Cancer

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Trial Information

Genital Drop Technique With Intensity-Modulated Radiation Therapy (IMRT) in Male Anal and Distal Rectal Cancer Patients: A Dosimetric Comparison


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Day 1. Pretreatment analysis.

Safety Issue:

No

Principal Investigator

Grant R. Seeger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Medical Branch at Galveston

Authority:

United States: Institutional Review Board

Study ID:

07-049

NCT ID:

NCT00693173

Start Date:

July 2007

Completion Date:

June 2009

Related Keywords:

  • Anal Cancer
  • anal
  • cancer
  • rectal
  • IMRT
  • genital
  • sparing
  • drop
  • technique
  • Anus Neoplasms
  • Rectal Neoplasms

Name

Location

The University of Texas Medical Branch at GalvestonGalveston, Texas  77550