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

NCT ID: NCT00568425

Last Updated: 2020-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:Histologically confirmed diagnosis of squamous cell carcinoma of the anus. Must be able to provide informed consent.

Exclusion Criteria

Exclusion Criteria:History of new malignancy since the time of treatment for anal cancer. Non-English speaking.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Lane Welton

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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96405

Identifier Type: OTHER

Identifier Source: secondary_id

SU-11062007-812

Identifier Type: OTHER

Identifier Source: secondary_id

ANAL0002

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-03103

Identifier Type: -

Identifier Source: org_study_id

NCT00533325

Identifier Type: -

Identifier Source: nct_alias

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