Clinical trial NCT03604653: Trial of Cytoreductive Surgery and HIPEC in Patients With Primary and Secondary Peritoneal Cancers
Official title: Trial of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Primary Peritoneal Cancers and Secondary Peritoneal Cancers From Stomach, Colorectal, Appendiceal, and/or Gynecological Origins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stomach Cancer
Colorectal Cancer
Appendiceal Cancer
Ovarian Cancer
Uterine Cancer
Cervical Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Keywords: HIPEC
Stomach cancer
colorectal cancer
appendiceal cancer
ovarian cancer
uterine cancer
cervical cancer
fallopian tube cancer
primary peritoneal carcinoma
intraperitoneal chemotherapy
Lead sponsor: Holy Name Medical Center, Inc.
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary peritoneal cancers and secondary peritoneal cancers from stomach, colorectal, appendiceal, and/or gynecological origins who are eligible by stage and pathology for surgical debulking and HIPEC, and who meet criteria to undergo an extensive operation.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

Age \>18

Diagnosis at the time of resection or on frozen section of:

* recurrent or primary stomach, colorectal or appendiceal cancer with regional spread that is confined to the peritoneal cavity
* primary peritoneal cancer
* ovarian cancer stage IC or higher
* uterine or cervical cancer stage IIA or higher with recurrence confined to the peritoneum
* fallopian tube cancer stage III or recurrence confined to the peritoneum ECOG performance status of 0,1, or 2

Lab values:

* absolute neutrophil count \>1500
* platelets \>100,000
* creatinine less than or equal to 2.0mg/dL
* bilirubin less than or equal to 1.5 times the upper limit of normal
* SGOT and alkaline phosphatase less than or equal to 2.5 times the upper limit of normal
* patients of childbearing age must have a negative serum pregnancy test and be using an effective form of contraception

Exclusion Criteria:

* Extra-peritoneal disease or unresectable disease
* Any known sensitivity to the chemotherapeutic agents used in the study
* Significant medical comorbidities that would prevent the patient from being able to complete the protocol (at discretion of investigator)
* Patients with gynecological malignancy who desire future fertility
* An informed consent cannot be obtained from the patient or power of attorney

Primary outcomes:
measure: Overall Survival
timeFrame: up to 10 years
measure: Disease-free Survival
timeFrame: up to 10 years
Secondary outcomes:
measure: Complications
timeFrame: 90 Days
measure: Treatment related quality of life changes as measured by the WHO QOL-BREF questionnaire
timeFrame: Up to 10 years
measure: Tumor Markers
timeFrame: up to 10 years
measure: Toxicity as measured by treatment related adverse events according to the NCI CTCAE v 4.0
timeFrame: 90 Days
Other outcomes:
Locations:
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
Study officials:
References: