Single Arm Study Treating Patients of Peritoneal Surface Malignancy (Colorectal, Appendical, Pseudomyxoma, Gastric) With Cytoreductive Surgery and Hyperthermic Intraperitoneal Mitomycin-C
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.
|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|
- 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.
- 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
- 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.
|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)|
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.
Other Name: Hyperthermic Intraperitoneal Chemotherapy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02040142
|United States, New York|
|Department of Surgery, Montefiore Medical Center- Weiler Division|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Timothy J Kennedy, M.D.||Department of Surgery, Montefiore Medical Center|