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Quality of Life and Functional Outcomes After Combined Modality Therapy for Anal Cancer: A Comparison of Conventional Versus Intensity-Modulated Radiation Therapy (ANAL0002)


N/A
30 Years
70 Years
Not Enrolling
Both
Anal Cancer

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Trial Information

Quality of Life and Functional Outcomes After Combined Modality Therapy for Anal Cancer: A Comparison of Conventional Versus Intensity-Modulated Radiation Therapy (ANAL0002)


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Evaluate the late effects of radiation treatment

Outcome Description:

Quality of life questionnaires

Outcome Time Frame:

one day

Safety Issue:

No

Principal Investigator

Mark Lane Welton

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

ANAL0002-

NCT ID:

NCT00568425

Start Date:

September 2005

Completion Date:

September 2009

Related Keywords:

  • Anal Cancer
  • Anus Neoplasms

Name

Location

Stanford University School of MedicineStanford, California  94305-5317