|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 4, 2007 | ||||
| Last Updated Date | November 19, 2008 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00568425 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT | ||||
| Official Title ICMJE | Quality of Life and Functional Outcomes After Combined Modality Therapy for Anal Cancer: A Comparison of Conventional Versus Intensity-Modulated Radiation Therapy (ANAL0002) | ||||
| 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. |
||||
| 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. |
||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Other | ||||
| Condition ICMJE | Anal Cancer | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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. |
||||
| Gender | Both | ||||
| Ages | 30 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00568425 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | SU-11062007-812, 96405, ANAL0002, NCT00568425 | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Stanford University | ||||
| Verification Date | November 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||