Trial of Cytoreductive Surgery and HIPEC in Patients With Primary and Secondary Peritoneal Cancers

August 2, 2022 updated by: Holy Name Medical Center, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stomach
Heated Intraperitoneal Chemotherapy with Mitomycin C 30mg at time 0, 10mg at time 45 minutes, CDDP Cisplatin 50mg/m2@ time 0
Device: HIPEC
Heated chemotherapy is pumped into the abdomen and circulated for 90 minutes
Other Names:
  • Chemo bath
Drug: Mitomycin c
MMC 30mg@ T0, 10mg@T45 min
Other Names:
  • MMC
Drug: CDDP 50
50mg/m2@T0
Other Names:
  • Cisplatin
Colorectal, Appendiceal, Pseudomyxoma Peritonei
Heated Intraperitoneal Chemotherapy with Mitomycin C 30mg at time 0, 10mg at time 45 minutes
Device: HIPEC
Heated chemotherapy is pumped into the abdomen and circulated for 90 minutes
Other Names:
  • Chemo bath
Drug: Mitomycin c
MMC 30mg@ T0, 10mg@T45 min
Other Names:
  • MMC
Primary Peritoneal
Heated Intraperitoneal Chemotherapy with CDDP Cisplatin 50mg/m2 at time 0, Doxorubicin 15mg/m2 at time 0
Device: HIPEC
Heated chemotherapy is pumped into the abdomen and circulated for 90 minutes
Other Names:
  • Chemo bath
Drug: CDDP 50
50mg/m2@T0
Other Names:
  • Cisplatin
Drug: Doxorubicin
15mg/m2@T0
Other Names:
  • DXR
Ovarian, Cervical, Uterine, Fallopian Tube
Heated Intraperitoneal Chemotherapy with CDDP Cisplatin 75mg/m2 at time 0
Device: HIPEC
Heated chemotherapy is pumped into the abdomen and circulated for 90 minutes
Other Names:
  • Chemo bath
Drug: CDDP 75
75mg/m2@T0
Other Names:
  • Cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: up to 10 years
Time from HIPEC treatment to death
up to 10 years
Disease-free Survival
Time Frame: up to 10 years
Time from HIPEC treatment to either recurrence or relapse of cancer, or death
up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 90 Days
Patients who undergo cytoreductive surgery followed by HIPEC will be monitored to record the incidence of the following complications: fistula, leak, pulmonary embolus, deep vein thrombosis, re-operation, hematologic
90 Days
Treatment related quality of life changes as measured by the WHO QOL-BREF questionnaire
Time Frame: Up to 10 years
Treatment related quality of life changes will be measured by the WHO QOL-BREF at each follow up visit
Up to 10 years
Tumor Markers
Time Frame: up to 10 years
Cancer-specific tumor markers will be measured 6 months post operatively and then yearly.
up to 10 years
Toxicity as measured by treatment related adverse events according to the NCI CTCAE v 4.0
Time Frame: 90 Days
Toxicity as measured by adverse events grade III-V according to NCI CTCAE v.4.0
90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holy Name Medical Center, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2018

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • holynameHIPEC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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