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

NCT01095367 | Terminated

• 1 other identifier: H09-03436
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Epithelial Ovarian Cancer

Keywords

Adhesion barrier sheets; ovarian cancer; Advanced stage epithelial ovarian cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  7-10 days

Secondary Outcomes (3)

• The safety and side effects of placement of Seprafilm, including fever, elevated WBC count, nausea, blocked port, port infection, small bowel obstruction

• The safety and side effects of IP omnipaque dye injection, including fever, elevated WBC count, nausea, blocked port, port infection, small bowel obstruction

• 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

Study Arms (2)

Seprafilm™

ACTIVE COMPARATOR

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™

No Seprafilm™

NO INTERVENTION

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.

Interventions

Seprafilm™ PROCEDURE

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.

Also known as: Adhesion Barrier sheets

Seprafilm™

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (2)

University of Nevada School of Medicine

Las Vegas, Nevada, United States

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Ovarian Neoplasms

Interventions

Seprafilm

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• 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

  STUDY DIRECTOR

• Sarah Finlayson, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 30, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2014
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

CA (1); US (1)