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QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00568425
Recruitment Status : Terminated (Inadequate response to Scientific Review Committee.)
First Posted : December 6, 2007
Last Update Posted : June 29, 2020
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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 or disease
Anal Cancer

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.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : September 2005
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Primary Outcome Measures :
  1. Evaluate the late effects of radiation treatment [ Time Frame: one day ]
    Quality of life questionnaires

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Histologically confirmed diagnosis of squamous cell carcinoma of the anus
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00568425

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Principal Investigator: Mark Lane Welton Stanford University
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Responsible Party: Stanford University Identifier: NCT00568425    
Obsolete Identifiers: NCT00533325
Other Study ID Numbers: IRB-03103
96405 ( Other Identifier: Stanford University Alternate IRB Approval Number )
SU-11062007-812 ( Other Identifier: Stanford University )
ANAL0002 ( Other Identifier: OnCore )
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Anus Neoplasms
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