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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

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Montefiore Medical Center Identifier:
First received: May 8, 2013
Last updated: January 16, 2014
Last verified: January 2014

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 Intervention Phase
Peritoneal Carcinomatosis
Colorectal Cancer
Appendiceal Cancer
Peritoneal Mesothelioma
Pseudomyxoma Peritonei
Gastric Cancer
Procedure: HIPEC
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Evaluate the technical parameters [ Time Frame: through subject discontinuation or 12 months after initial study treatment ] [ Designated as safety issue: Yes ]
    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:
  • Progression-free survival [ Time Frame: up until 5 years ] [ Designated as safety issue: Yes ]

    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:
  • Overall survival [ Time Frame: Up until 5 years. ] [ Designated as safety issue: Yes ]
    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.

  • Quality of life [ Time Frame: Up until 5 years ] [ Designated as safety issue: No ]
    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.

  • Genomic and Epigenetic Associated with HIPEC [ Time Frame: Day 1 of surgery ] [ Designated as safety issue: No ]
    During the cytoreductive surgery, we will collect a small sample of normal peritoneal tissue and an adjacent area of peritoneum that contains tumor deposits. A small piece of peritoneal tumor will be left in situ in the abdominal cavity for the hyperthermic peritoneal perfusion. Following perfusion, the residual peritoneal tumor and adjacent normal peritoneum will be excised and collected. These specimens will be analyzed to look for genomic and epigenetic changes in normal and cancerous tissue that has been treated with hyperthermic intraperitoneal chemotherapy.

Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02040142

United States, New York
Department of Surgery, Montefiore Medical Center- Weiler Division
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Principal Investigator: Timothy J Kennedy, M.D. Department of Surgery, Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Montefiore Medical Center Identifier: NCT02040142     History of Changes
Other Study ID Numbers: 11-09-332
Study First Received: May 8, 2013
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Montefiore Medical Center:
Hyperthermic Intraperitoneal Mitomycin c

Additional relevant MeSH terms:
Pseudomyxoma Peritonei
Colorectal Neoplasms
Neoplasms, Mesothelial
Stomach Neoplasms
Body Temperature Changes
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Glandular and Epithelial
Rectal Diseases
Signs and Symptoms
Stomach Diseases
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on November 19, 2014