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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00693173
First received: June 4, 2008
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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.


Condition
Anal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Genital Drop Technique With Intensity-Modulated Radiation Therapy (IMRT) in Male Anal and Distal Rectal Cancer Patients: A Dosimetric Comparison

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • The Genital Drop Technique (IMRT-GD) decreased the radiation dose to the testicles scrotal skin and penile shaft compared to standard prone technique. [ Time Frame: Day 1. Pretreatment analysis. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Dosimetry comparison details. [ Time Frame: Day 1. Pretreatment parameters. ] [ Designated as safety issue: No ]

    Testicular dose: Volume receiving 14 Gy was 90% with CRT, 64% with IMRT, and 3% with IMRT-GD.

    Testicular dose: Volume receiving 30 Gy was 54% with CRT, 26% with IMRT, and 0% with IMRT-GD.

    External genitalia dose: Volume receiving 14 Gy was 93% with CRT, 79% with IMRT, and 35% with IMRT-GD.

    External genitalia dose: Volume receiving 30 Gy was 75% with CRT, 31% with IMRT, and 12% with IMRT-GD.

    Planning Target Volume receiving full 54 Gy dose was 93% with CRT, 93% with IMRT, and 94% with IMRT-GD.



Enrollment: 14
Study Start Date: July 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693173

Locations
United States, Texas
The University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77550
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: Grant R. Seeger, MD The University of Texas Medical Branch at Galveston
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00693173     History of Changes
Other Study ID Numbers: 07-049
Study First Received: June 4, 2008
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
anal
cancer
rectal
IMRT
genital
sparing
drop
technique

Additional relevant MeSH terms:
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014