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NCT00568425 Clinical Trial

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

Anal Cancer Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00568425
Other study ID # IRB-03103
Secondary ID 96405SU-11062007
Status Terminated
Phase
First received
Last updated
Start date September 2005
Est. completion date September 2009

Study information
Verified date June 2020
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Other known NCT identifiers
  • NCT00533325

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the late effects of radiation treatment Quality of life questionnaires one day
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