Single Arm Study Treating Patients of Peritoneal Surface Malignancy (Colorectal, Appendical, Pseudomyxoma, Gastric) With Cytoreductive Surgery and Hyperthermic Intraperitoneal Mitomycin-C
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|ClinicalTrials.gov Identifier: NCT02040142|
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : January 11, 2021
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
Drug: Mitomycin C
- 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.
- 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
- 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.
- 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.
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): NCT02040142
|United States, New York|
|Department of Surgery, Montefiore Medical Center- Weiler Division|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Haejin In, M.D.||Department of Surgery, Montefiore Medical Center|