Seprafilm™ for the Prevention of Intraperitoneal Adhesions and Improved Delivery of Therapy in Women Undergoing Staging and Intraperitoneal Chemotherapy for Advanced Ovarian Cancer
| Status: | Completed |
|---|---|
| Conditions: | Ovarian Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/8/2014 |
| Start Date: | April 2010 |
| End Date: | December 2012 |
| Contact: | Jessica McAlpine, MD |
| Email: | jessica.mcalpine@vch.ca |
| Phone: | 604 877-6000 |
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.
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.
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™).
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™).
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)
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