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

NCT03604653 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2022-08-03

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

HIPEC

Heated chemotherapy is pumped into the abdomen and circulated for 90 minutes

DRUG

Mitomycin c

MMC 30mg@ T0, 10mg@T45 min

DRUG

CDDP 50

50mg/m2@T0

DRUG

CDDP 75

75mg/m2@T0

DRUG

Doxorubicin

15mg/m2@T0

Sponsors & Collaborators

  • Holy Name Medical Center, Inc.

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-15
Primary Completion
2021-05-01
Completion
2021-05-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03604653 on ClinicalTrials.gov