Seprafilm™ for the Prevention of Intraperitoneal Adhesions and Improved Delivery of Therapy in Women Undergoing Staging and Intraperitoneal Chemotherapy for Advanced Ovarian Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01095367
First received: March 22, 2010
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

The purpose of this research is to determine if a film to prevent adhesions will improve the area of distribution of a contrast dye (representative of chemotherapy) in the abdominal cavity (belly) of women who have undergone surgery for ovarian cancer as compared with patients who have not had adhesion barrier sheets placed in the belly. It is believed that this film, Seprafilm™, reduces adhesions (scar tissue between tissues and organs) in the abdominal cavity following surgery. Adhesions can limit the distribution of the chemotherapy agent placed in the abdomen to treat the ovarian cancer. Thirty subjects will receive adhesion barrier sheets and thirty will not. To determine if the sheets prevent adhesions, all subjects will have a dye inserted into the abdomen and then have X-rays of the abdomen to look at the distribution of the dye between the two groups.

Hypothesis:

Null hypothesis: There is no difference in area of distribution of the intraperitoneal dye in the Seprafilm ™ vs. no Seprafilm™ groups.

Alternative hypothesis: Seprafilm™ reduces adhesion formation and there is a larger area of distribution of intraperitoneal dye in the Seprafilm™ group.


Condition Intervention
Epithelial Ovarian Cancer
Procedure: Seprafilm™

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Seprafilm™ for the Prevention of Intraperitoneal Adhesions and Improved Delivery of Therapy in Women Undergoing Staging and Intraperitoneal Chemotherapy for Advanced Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The area of distribution of contrast dye in the intraperitoneal cavity as measured on three abdominal films taken 7-10 days following debulking surgery for epithelial ovarian cancer. [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety and side effects of placement of Seprafilm, including fever, elevated WBC count, nausea, blocked port, port infection, small bowel obstruction [ Designated as safety issue: No ]
  • The safety and side effects of IP omnipaque dye injection, including fever, elevated WBC count, nausea, blocked port, port infection, small bowel obstruction [ Designated as safety issue: No ]
  • The additional time taken for 1) placement of Seprafilm, 2) injection of IP contrast dye, 3) obtaining 3-way abdominal X-rays, and 4) interpretation of films [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Seprafilm™
Subject will have 3 sheets of Seprafilm™ placed in her abdominal cavity (in the pelvis, upper abdomen and below the incision) at the end of debulking surgery. At 7-21 days after surgery the subject will receive a contrast dye, Iohexol (Omnipaque™), into her intraperitoneal port. The subject will then undergo 3 abdominal X-rays, to assess the extent of abdominal adhesions.
Procedure: Seprafilm™

Seprafilm™ Adhesion Barrier is an approved temporary, bioresorbable adhesion barrier to reduce the incidence, extent, and severity of adhesions in patients undergoing abdominal or pelvic laparotomy.

Seprafilm sheets are size 5" x 6" individually-wrapped, sterile membranes. Three or more Seprafilm™ sheets will be placed in the randomized cohort.

Other Name: Adhesion Barrier sheets
No Intervention: No Seprafilm™
Subject will undergo debulking surgery without Seprafilm™ placement (standard care). At 7-21 days after surgery the subject will receive a contrast dye, Iohexol (Omnipaque™), into her intraperitoneal port. The subject will then undergo 3 abdominal X-rays, to assess the extent of abdominal adhesions.

Detailed Description:

The recommended treatment of epithelial ovarian cancer (EOC) includes optimal surgical debulking to < 1 cm residual disease, followed by a combination of intraperitoneal (IP) and intravenous (IV) chemotherapy for at least 6 cycles. Serous EOC is known to spread transperitoneally and is often diffusely disseminated within the peritoneal cavity. It is believed that IP therapy via direct contact is effective in treating such small intraperitoneal implants. What is not known is whether IP therapy is evenly distributed in individuals and to what degree adhesions and formation of scar tissue prevents the even distribution of chemotherapy within the belly, potentially impacting efficacy. Few studies have addressed the question of adhesions and intraperitoneal therapy in general, and there have been no studies specifically in ovarian cancer utilizing current guidelines. Efficacy has been proven for IP/IV therapy over IV alone but the range of survival within the IP group may be secondary to "tumor biology," patient selection (i.e., disease truly > 1 cm) or lack of/poor distribution of IP drug secondary to adhesions. Any product that could be shown to decrease those adhesions and increase the area of distribution of IP therapy would prove a major advantage.

The majority of scarring and adhesions take place in the first 7 days after a surgical procedure. And the first IP and IV chemotherapy usually commences between 7-21 days after surgery. Therefore, the first treatment provides an opportunity to assess intraperitoneal adhesions. To assess adhesions, we will inject radiopaque dye (iohexol) via the IP port, rotate the patient per the standard practice during IP therapy to distribute the injected liquid, and then take 3 views (simple X-rays) of the abdomen. The area of distribution of the dye (representing distribution of IP chemotherapy) will be compared in two groups of subjects (Seprafilm™ vs. no Seprafilm™).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Epithelial ovarian cancer
  • Stage III or IV (advanced)
  • Planned intraperitoneal chemotherapy
  • Optimally debulked to less than 1 cm residual tumor in any area within the peritoneal cavity (after consent prior to randomization)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095367

Contacts
Contact: Jessica McAlpine, MD 604 877-6000 jessica.mcalpine@vch.ca

Locations
United States, Nevada
University of Nevada School of Medicine Recruiting
Las Vegas, Nevada, United States
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Genzyme, a Sanofi Company
Investigators
Study Director: Dr. Dianne Miller British Columbia Cancer Agency
Study Director: Mark S Carey, MD University of British Columbia
Study Director: Thomas G Ehlen, MD University of British Columbia
Principal Investigator: Sarah Finlayson, MD University of British Columbia
Study Director: Janice Kwon, MD University of British Columbia
Study Director: Gavin CE Stuart, MD University of British Columbia
Study Director: Anna Tinker, MD British Columbia Cancer Agency
Study Director: Mark Heywood, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01095367     History of Changes
Other Study ID Numbers: H09-03436
Study First Received: March 22, 2010
Last Updated: November 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Adhesion barrier sheets
ovarian cancer
Advanced stage epithelial ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 22, 2014