Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Supportive care | Active | 18 and over | NCI | MSKCC-02124 NCT00059891 |
Objectives
- Determine the risk of complications and feasibility of total anorectal reconstruction using the Acticon Neosphincter prosthesis after abdominoperineal resection in patients with anal or rectal cancer.
- Determine continence, bowel function, and quality of life of patients treated with this surgery.
Entry Criteria
Disease Characteristics:
- Histologically confirmed distal rectal or anal cancer
- No recurrent or metastatic disease
- Not at high risk for local recurrence
- Not a candidate for sphincter-preserving surgery
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Other
- Not other concurrent investigational products
Patient Characteristics:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No active pelvic sepsis
- Acceptable risk for surgery and general anesthesia
- Sufficient dexterity and mental capacity to operate the Acticon Neosphincter prosthesis
Expected Enrollment
20At least 20 patients will be accrued for this study.
Outline
Patients undergo abdominoperineal resection (APR) with perineal colostomy and diverting loop ileostomy. At least 3 months after APR, patients undergo placement of the Acticon Neosphincter prosthesis. At least 6 weeks after prosthesis placement, the prosthesis is activated. When the patient demonstrates the ability to operate the prosthesis, the ileostomy is reversed.
Quality of life is assessed at 6 and 12 months and then annually thereafter.
Patients are followed at 6 and 12 months and then annually thereafter.
Trial Lead Organizations
Memorial Sloan-Kettering Cancer Center
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| W. Douglas Wong, MD, Protocol chair | |
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| U.S.A. | |||||||
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| New York | |||||||
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| Memorial Sloan-Kettering Cancer Center | |||||||
| W. Douglas Wong, MD |
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| Registry Information | ||
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| Official Title | Total Anorectal Reconstruction With The American Medical Systems, Inc. Acticon Neosphincter Prosthesis After Abdominoperineal Resection | |
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| Trial Start Date | 2003-01-14 | |
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| Trial Completion Date | 2010-01-14 (estimated) | |
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| Registered in ClinicalTrials.gov | NCT00059891 | |
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| Date Submitted to PDQ | 2003-03-12 | |
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| Information Last Verified | 2009-07-21 | |
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| NCI Grant/Contract Number | P30-CA08748 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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