Epithelial Ovarian CancerNCT01095367
Seprafilm™ for the Prevention of Intraperitoneal Adhesions and Improved Delivery of Therapy in Women Undergoing Staging and Intraperitoneal Chemotherapy for Advanced Ovarian Cancer
A study testing Seprafilm™ in people with Epithelial Ovarian Cancer, run by University of British Columbia at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Seprafilm™
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2010to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Nevada School of Medicine
Las Vegas, Nevada
About this study
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:
Read more
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.
Read the 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™).
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Seprafilm™
- Keywords
- Adhesion barrier sheets, ovarian cancer, Advanced stage epithelial ovarian cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seprafilm™Procedure or surgery
Also called Adhesion Barrier sheets
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2012
- Study completionJan 2014
Why it stopped: due to company changes and lack of funding-unlikely to have sufficient numbers to analyze meaningfully
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Dr. Dianne Miller, Study director, British Columbia Cancer AgencyMark S Carey, MD, Study director, University of British ColumbiaThomas G Ehlen, MD, Study director, University of British ColumbiaSarah Finlayson, MD, Principal investigator, University of British ColumbiaJanice Kwon, MD, Study director, University of British ColumbiaGavin CE Stuart, MD, Study director, University of British ColumbiaAnna Tinker, MD, Study director, British Columbia Cancer AgencyMark Heywood, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095367
- Sponsor's protocol ID
- H09-03436
- Status last verified
- Sep 2014
- First submitted
- 22 Mar 2010
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01095367
- Acronym / sponsor ID
- H09-03436
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- Adhesion barrier sheets, ovarian cancer, Advanced stage epithelial ovarian cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to company changes and lack of funding-unlikely to have sufficient numbers to analyze meaningfully
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Apr 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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™).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seprafilm™ | Active comparator | Procedure: 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seprafilm™Also: Adhesion Barrier sheetsSeprafilm™ 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. | Procedure or surgery | Seprafilm™ |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: due to company changes and lack of funding-unlikely to have sufficient numbers to analyze meaningfully). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Dianne Miller study director
British Columbia Cancer Agency
Mark S Carey, MD study director
University of British Columbia
Thomas G Ehlen, MD study director
University of British Columbia
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seprafilm™ in people with Epithelial Ovarian Cancer, run by University of British Columbia at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to company changes and lack of funding-unlikely to have sufficient numbers to analyze meaningfully). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2014.