Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03604653
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Holy Name Medical Center, Inc.

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.


Condition or disease Intervention/treatment
Stomach Cancer Colorectal Cancer Appendiceal Cancer Ovarian Cancer Uterine Cancer Cervical Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Device: HIPEC Drug: Mitomycin c Drug: CDDP Drug: Doxorubicin

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021


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

Drug: Mitomycin c
MMC 30mg@ T0, 10mg@T45 min

Drug: CDDP
50mg/m2@T0
Other Name: 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

Drug: Mitomycin c
MMC 30mg@ T0, 10mg@T45 min

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

Drug: CDDP
50mg/m2@T0
Other Name: Cisplatin

Drug: Doxorubicin
15mg/m2@T0

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

Drug: CDDP
75mg/m2@T0
Other Name: Cisplatin




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: up to 10 years ]
    Time from HIPEC treatment to death

  2. Disease-free Survival [ Time Frame: up to 10 years ]
    Time from HIPEC treatment to either recurrence or relapse of cancer, or death


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Tumor Markers [ Time Frame: up to 10 years ]
    Cancer-specific tumor markers will be measured 6 months post operatively and then yearly.

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604653


Contacts
Layout table for location contacts
Contact: Sung Kwon, MD 201-541-5989 steve-kwonmd@mail.holyname.org
Contact: Julie Schwegman, PAC 201-541-5989 schwegman@holyname.org

Locations
Layout table for location information
United States, New Jersey
Holy Name Medical Center Recruiting
Teaneck, New Jersey, United States, 07666
Contact: Sung Kwon, MD    201-541-5989    steve-kwonmd@mail.holyname.org   
Contact: Julie Schwegman, PAC    201-541-5989    schwegman@holyname.org   
Principal Investigator: Sung Kwon, MD         
Principal Investigator: Sharyn Lewin, MD         
Principal Investigator: Maria Schiavone, MD         
Sponsors and Collaborators
Holy Name Medical Center, Inc.

Layout table for additonal information
Responsible Party: Holy Name Medical Center, Inc.
ClinicalTrials.gov Identifier: NCT03604653     History of Changes
Other Study ID Numbers: holynameHIPEC1
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Holy Name Medical Center, Inc.:
HIPEC
Stomach cancer
colorectal cancer
appendiceal cancer
ovarian cancer
uterine cancer
cervical cancer
fallopian tube cancer
primary peritoneal carcinoma
intraperitoneal chemotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Fallopian Tube Neoplasms
Stomach Neoplasms
Uterine Neoplasms
Appendiceal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Cervical Diseases
Uterine Diseases
Fallopian Tube Diseases
Stomach Diseases
Cecal Neoplasms