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Single Arm Study Treating Patients of Peritoneal Surface Malignancy (Colorectal, Appendical, Pseudomyxoma, Gastric) With Cytoreductive Surgery and Hyperthermic Intraperitoneal Mitomycin-C

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. Read our disclaimer for details. Identifier: NCT02040142
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : January 11, 2021
Information provided by (Responsible Party):
Haejin In, Albert Einstein College of Medicine

Brief Summary:

This is a clinical study investigating the new treatment of surgery combined with intraperitoneal mitomycin-C for patients with gastrointestinal cancer that has spread to the peritoneal (abdominal cavity) surface. Mitomycin-C to be used in this procedure is approved by the U.S. Food and Drug Administration (FDA)for many different cancers including gastrointestinal cancer. Giving mitomycin C via the intraperitoneal route is not FDA approved and is an investigation therapy. Cytoreductive surgery plus intraperitoneal chemotherapy can be offered as standard of care outside of a clinical trial. However, since this is an unproven and potentially more effective but a more toxic approach, the investigators are performing this procedure under an IRB approved clinical trial in order to better evaluate the risks and benefits of this approach.

A standardized, evidence-based approach is currently lacking for patients with peritoneal surface malignancy from gastrointestinal origin. A clinical trial with surgical quality assurance and modern hyperthermic intraperitoneal chemotherapy incorporating critical assessment of disease burden, determinants of complete cytoreduction, treatment-related toxicity, quality of life and survival is imperative. Theoretically, cytoreductive surgery is performed to treat macroscopic disease, and hyperthermic intraperitoneal chemotherapy is used to treat microscopic residual disease with the objective of removing disease completely in a single procedure.

Condition or disease Intervention/treatment Phase
Peritoneal Carcinomatosis Colorectal Cancer Appendiceal Cancer Peritoneal Mesothelioma Pseudomyxoma Peritonei Gastric Cancer Procedure: HIPEC Drug: Mitomycin C Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm Study Treating Patients of Peritoneal Surface Malignancy (Colorectal, Appendical, Pseudomyxoma, Gastric) With Cytoreductive Surgery and Hyperthermic Intraperitoneal Mitomycin-C
Study Start Date : November 2011
Actual Primary Completion Date : October 31, 2020
Actual Study Completion Date : November 9, 2020

Arm Intervention/treatment
Experimental: HIPEC + Mitomycin C
HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, will be administered into the inflow line of the perfusion circuit once target temperature is reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, will be administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period has elapsed, the perfusate will be drained into the waste reservoir. The peritoneal cavity will be rinsed/washed-out.
Procedure: HIPEC
Other Name: Hyperthermic Intraperitoneal Chemotherapy

Drug: Mitomycin C

Primary Outcome Measures :
  1. Evaluate the technical parameters [ Time Frame: through subject discontinuation or 12 months after initial study treatment ]
    This prospective trial will evaluate the technical parameters including completeness of cytoreduction, achievement of hyperthermia, morbidity and mortality in patients with peritoneal carcinomatosis of colorectal, gastric, appendical, pseudomyxoma peritonei and peritoneal mesothelioma origin undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with Mitomycin- C.

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: up until 5 years ]

    Determination of disease progression will be based on:

    • Radiological (CT ± PET), and/or
    • Surgical (laparoscopic or open exploration) evidence of recurrent disease. Peritoneal disease progression will be confirmed by cytology or histology revealing cells morphologically consistent with malignant tumor cells

Other Outcome Measures:
  1. Overall survival [ Time Frame: Up until 5 years. ]
    Overall survival (OS) is defined as the time from operation date to death from any cause. OS will be censored at the date of last follow up visit for patients who are still alive or lost to follow up.

  2. Patient Reported Outcomes [ Time Frame: Up until 5 years ]
    Quality of life measurements will be determined before treatment (baseline) and at 3-month intervals using the Functional Assessment of Cancer Treatment (FACT) instrument. The QOL will be provided in English and in other languages upon request. If a language other than English is needed to complete the forms, certified translated versions will be used. It is anticipated that the noncompliance of completion of QOL questionnaires may occur.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age ≥ 18 years
  • Capable of providing informed consent.
  • The patient who has not previously received hyperthermic intraperitoneal chemotherapy must have histopathologically or cytologically confirmed cancer of colorectal, appendiceal, peritoneal mesothelioma, pseudomyxoma or gastric origin with known synchronous or metachronous disease dissemination limited to the peritoneal surfaces.
  • The patient must have documented disease limited to the peritoneal surface, amenable to complete cytoreduction indicated by:

    • Disease confined to the peritoneal surfaces
    • No parenchymal liver metastases
    • No evidence of clinical, biochemical or radiological biliary obstruction
    • Small volume of disease in the gastro-hepatic ligament defined by a < 5cm mass in the epigastric region on cross-sectional imaging
    • No clinical or radiological evidence of hematogenous or distant nodal metastasis
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Absolute neutrophil count (ANC) > 1200/mm3, white blood cell count (WBC) > 4000/mm3 and platelet count > 150,000/mm3
  • An international normalized ratio (INR) ≤ 1.5 (patients who are therapeutically anticoagulated for unrelated medical conditions such as atrial fibrillation and whose antithrombotic treatment can be withheld for operation will be eligible).
  • Adequate hepatic function must be met as evidenced by total serum bilirubin ≤ 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert's syndrome);

    • alkaline phosphatase < 2.5 times the upper limit of normal; and/or
    • AST < 1.5 times upper limit of normal (alkaline phosphatase and AST cannot both exceed the upper limit of normal
  • Serum renal functional parameters, blood urea nitrogen (BUN) and creatinine are within normal limits
  • Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal - cytoreductive surgery).
  • Patients who have met the above criteria and who have undergone CRS and HIPEC in the past 18 months for the beforementioned disease processes without evidence of recurrence will be eligible for participation in this study for analyzing ability to achieve complete cytoreduction, morbidity, progression and survival.

Exclusion Criteria:

  • The patients have documented disease beyond the peritoneal surfaces, which prevent achieving complete cytoreduction as indicated by:

    • Evidence of distant hematogenous metastatic disease or distant nodal metastases
    • Evidence of parenchymal hepatic metastases
    • Evidence of clinical, biochemical or radiological biliary obstruction
    • Evidence of gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity which limits ability to obtain complete cytoreduction
  • Significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease.
  • Active systemic infections, coagulation disorders, or other major medical illnesses precluding major surgery.
  • Childs B or C cirrhosis or with evidence of severe portal hypertension by history, endoscopy or radiologic studies.

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 identifier (NCT number): NCT02040142

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United States, New York
Department of Surgery, Montefiore Medical Center- Weiler Division
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
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Principal Investigator: Haejin In, M.D. Department of Surgery, Montefiore Medical Center
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Responsible Party: Haejin In, Asst Prof Surgery, Albert Einstein College of Medicine Identifier: NCT02040142    
Other Study ID Numbers: 11-09-332
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Haejin In, Albert Einstein College of Medicine:
Hyperthermic Intraperitoneal Mitomycin c
Additional relevant MeSH terms:
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Peritoneal Neoplasms
Pseudomyxoma Peritonei
Appendiceal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Abdominal Neoplasms
Peritoneal Diseases
Body Temperature Changes
Neoplasms, Cystic, Mucinous, and Serous
Cecal Neoplasms
Cecal Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action