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| Sponsor: | 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 |
| Study Type: | Observational |
| Study Design: | 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) |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
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 |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Mark Lane Welton | Stanford University |
More Information
| Responsible Party: | Mark Lane Welton, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00568425 History of Changes |
| Obsolete Identifiers: | NCT00533325 |
| Other Study ID Numbers: | SU-11062007-812, 96405, ANAL0002 |
| Study First Received: | December 4, 2007 |
| Last Updated: | February 17, 2010 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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Anus Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases |
