Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03604653 |
| Other study ID # |
holynameHIPEC1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2018 |
| Est. completion date |
May 1, 2021 |
Study information
| Verified date |
August 2022 |
| Source |
Holy Name Medical Center, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Patients with primary peritoneal cancer or secondary peritoneal cancers from stomach,
colorectal, appendiceal, and gynecological primary origin will be screened by pathology and
staging to see if they are eligible to undergo cytoreductive surgery combined with
hyperthermic intraperitoneal chemotherapy (HIPEC).
To be eligible for the study, patients must be over 18 years of age, have appropriate
pathology and stage with disease confined to the peritoneal cavity, have a good performance
status, have laboratory values that fall within safe ranges to undergo an operation and
receive intraperitoneal chemotherapy. The chemotherapeutic agent and dose will be assigned
based on pathological diagnosis in accordance with current standard of care.
Surgery will be performed with the goal of removing all visible tumor that may require
removal of adjacent organs. Once only microscopic disease is present, the chemotherapy will
be delivered directly into the peritoneum via intraperitoneal hyperthermia and perfusion
device. This will continue for 90 minutes.
Patients will be followed for tumor response, survival, toxicity, complications, quality of
life, and tumor markers. They will have regular follow up visits with the surgeon, undergo
routine surveillance imagings, and receive follow up phone calls periodically.
Description:
Peritoneal carcinomatosis can be caused by primary peritoneal cancers and secondary
peritoneal spread from stomach, colorectal, appendiceal, and/or gynecological cancers.
Combined presentation of patients with peritoneal carcinomatosis make up about 67,000 new
cancer diagnoses each year. Of these cases, about 25,000 patients are estimated to be
candidates for cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy
(HIPEC); however, in 2009 only five percent of these patients received such treatment.
Alternative therapies to cytoreductive surgery and HIPEC are few. They include surgical
treatments with cytoreduction alone which are palliative in nature and inadequate to manage
the disease, radiation which is limited in regard to tumors disseminated throughout abdominal
cavity, systemic chemotherapy which has poor penetration into the peritoneum. Intraperitoneal
chemotherapy via indwelling peritoneal catheter is limited due to port infections, toxicity,
and unequal distribution in the abdominal cavity.
For patients whose disease is limited to the peritoneal cavity, multi-modality treatment with
cytoreductive surgery followed by intraoperative HIPEC can deliver chemotherapy directly to
microscopic tumors at a higher concentration than is tolerated systemically. It causes
disruption of cell membranes and induces apoptosis. Moreover when intraperitoneal
chemotherapy is given at a higher temperature, it has a selective lethal effect on cancer
cells secondary to improved tissue absorption. The typical side effects of systemic
chemotherapy are also minimized with HIPEC.
HIPEC is given intraoperatively in one treatment setting after all visible disease has been
resected (i.e., cytoreductive surgery). The goal of cytoreductive surgery is to leave behind
only microscopic disease and may require removal of adjacent organs. HIPEC is then delivered
via tubings with temperature probes that are placed in the intraperitoneal cavity. The skin
is then temporarily closed and the tubings are connected to a intraperitoneal hyperthermia
and perfusion device that delivers sterile solution with chemotherapy into the abdomen. The
device heats and circulates the chemotherapy for 90 minutes. After HIPEC is completed,
abdomen is reopened and copiously irrigated. Surgical reconstruction with any removed organs
(such as bowel) and fascial/skin closure are the final steps.
Previous studies have shown conflicting results on survival benefit for patients with some of
the aforementioned secondary peritoneal cancers who have undergone cytoreductive surgery and
HIPEC. This study is an outcomes based study that seeks to look at the impact of HIPEC on
overall survival and recurrence-free survival.
