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QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT
This study is currently recruiting participants.
Verified by Stanford University, November 2008
First Received: December 4, 2007   Last Updated: November 19, 2008   History of Changes
Sponsored by: Stanford University
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00568425
  Purpose

The purpose of this study is show that intensity-modulated radiotherapy (IMRT), as compared with conventional radiotherapy, improves the precision of tumor targeting and reduces the acute and late effects of radiation toxicity when used to treat anal cancer. Results from this work will provide a basis for incorporating the use of IMRT to treat anal cancer in future treatment protocols.


Condition
Anal Cancer

MedlinePlus related topics: Anal Cancer Cancer Radiation Therapy
U.S. FDA Resources
Study Type: Observational
Official Title: Quality of Life and Functional Outcomes After Combined Modality Therapy for Anal Cancer: A Comparison of Conventional Versus Intensity-Modulated Radiation Therapy (ANAL0002)

Further study details as provided by Stanford University:

Estimated Enrollment: 30
Study Start Date: September 2005
Detailed Description:

The objectives of this study are three-fold. First, we would like to learn and compare the doses of radiation received by the tumor and the normal tissues in anal cancer patients treated with IMRT, and in those treated with conventional radiotherapy.

Second, we wish to compare the acute effects of radiation treatment in both groups of patients. Our third objective is to evaluate the late effects of radiation treatment in both groups of patients. The first two objectives will be studied using a retrospective analysis of patients with anal cancer treated at Stanford University Medical Center. The third objective will require these patients to complete and return three quality of life questionnaires.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Histologically confirmed diagnosis of squamous cell carcinoma of the anus. Must be able to provide informed consent.
 Exclusion Criteria:History of new malignancy since the time of treatment for anal cancer. Non-English speaking.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568425

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Moe Jalali     650-724-4023     moej@stanford.edu    
Contact: Cancer Clinical Trials Office     (650) 498-7061        
Principal Investigator: Mark Lane Welton            
Sub-Investigator: Albert Koong            
Sub-Investigator: Brett Cox            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Mark Lane Welton Stanford University
  More Information

No publications provided

Study ID Numbers: SU-11062007-812, 96405, ANAL0002, NCT00568425
Study First Received: December 4, 2007
Last Updated: November 19, 2008
ClinicalTrials.gov Identifier: NCT00568425     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Rectal Neoplasm
Quality of Life
Intestinal Diseases
Anal Cancer
Rectal Diseases
Intestinal Neoplasms
Digestive System Diseases
Rectal Cancer
Gastrointestinal Neoplasms
Anus Neoplasms
Colorectal Neoplasms

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

ClinicalTrials.gov processed this record on May 06, 2009