Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Active 18 and over NCI MSKCC-02124 NCT00059891

Objectives

1. 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.
2. 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

At 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 Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

W. Douglas Wong, MD, Protocol chair		Ph: 212-639-5117; 800-525-2225

U.S.A.
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		W. Douglas Wong, MD	Ph:  212-639-5117 800-525-2225

Registry Information
Official Title		Total Anorectal Reconstruction With The American Medical Systems, Inc. Acticon Neosphincter Prosthesis After Abdominoperineal Resection
Trial Start Date		2003-01-14
Trial Completion Date		2009-01-14 (estimated)
Registered in ClinicalTrials.gov		NCT00059891
Date Submitted to PDQ		2003-03-12
Information Last Verified		2008-03-30
NCI Grant/Contract Number		P30-CA08748

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