Comparing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC) Using Mitomycin-C Versus Melphalan for Colorectal Peritoneal Carcinomatosis
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|ClinicalTrials.gov Identifier: NCT03073694|
Recruitment Status : Not yet recruiting
First Posted : March 8, 2017
Last Update Posted : March 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer, Appendiceal ColoRectal Cancer||Drug: Mitomycin c Drug: Melphalan||Phase 2|
BACKGROUND: Peritoneal dissemination of cancer (peritoneal carcinomatosis) from gastrointestinal malignancies, meaning tumor deposits along the inside abdominal or pelvic wall and surfaces of the intestines and organs, has historically been considered a terminal disease. Although peritoneal surface tumors can respond to systemic therapy as a sole form of treatment, patient survival remains poor and cure is considered impossible.
A plasma-peritoneal barrier makes systemic therapy relatively ineffective against peritoneal surface disease. In the 1990's, cytoreductive surgery and hyperthermic intraperitoneal therapy (CRS-HIPEC) began to be popularized as a more effective treatment.
Hyperthermic intraperitoneal chemotherapy has several advantages. High-dose chemotherapy can be used due to the plasma-peritoneal barrier resulting in little absorption into the blood stream. Hyperthermia itself has cytotoxic effects and can increase the depth of tumor penetration by the chemotherapeutic agent up to 3 mm and moreover can potentiate its antineoplastic effects. Although CRS-HIPEC has been considered standard treatment for ruptured appendiceal neoplasms and primary peritoneal mesothelioma, in the past decade its indications have broadened to other peritoneal surface malignant processes.
Historically, morbidity and mortality associated with CRS-HIPEC was considerably higher than other complex operations, and thus its use was often discouraged. However, in recent times, especially in high-volume centers, morbidity and mortality has drastically improved. Due to recent improvements in mortality after major surgical interventions, including HIPEC, the focus has shifted toward other endpoints besides efficacy, such as morbidity, quality of life and cost.
While HIPEC is universally felt to be a vital component after cytoreductive surgery, there is a lack of consensus on the optimal regimen, especially the chemotherapeutic agent that should be used. In the United States, the most commonly used agent during HIPEC is mitomycin-C, however, it remains unknown if mitomycin-C is the optimal drug to use with regards to toxicity and survival.
Randomized prospective studies are needed comparing the toxicity and effectiveness of HIPEC with mitomycin-C to other agents.
OBJECTIVE: To compare morbidity and mortality after CRS-HIPEC utilizing mitomycin-C versus melphalan.
METHODS: In this study, patients will be randomized to one of two treatment arms: Arm 1.) Mitomycin-C initial dose of 15 mg/m2, 45 minutes into the perfusion a maintenance dose of 5 mg/m2 will be administered; or Arm 2): Melphalan 60 mg/m2 45 minutes into the perfusion. Morbidity will be measured during immediate and short-term surgical recovery (up to 90 days post-hospital discharge). Mortality will be measured beginning with the date of surgery and ending with the date of participant death.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase II Single-Blind Randomized Trial Comparing Morbidity of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC) Using Mitomycin-C Versus Melphalan for Colorectal Peritoneal Carcinomatosis|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2025|
Active Comparator: Mitomycin C Group
Mitomycin-C initial dose of 15 mg/m2 (milligrams per meter squared) 45 minutes into the perfusion, a maintenance dose of 5 mg/m2 will be administered.
Drug: Mitomycin c
Mitomycin-c will be given to participants in Treatment Arm 1 as a one-time, intraoperative, intravenous administration for a duration of 90 minutes. 45 minutes into the perfusion, a maintenance dose will be administered.
Experimental: Melphalan Group
Melphalan 60 mg/m2 (milligrams per meter squared) 45 minutes into the perfusion.
Melphalan will be given to participants in Treatment Arm 2 as a one-time, intraoperative, intravenous administration for a duration of 90 minutes.
Other Name: Alkeran
- Comprehensive Complication Index (CCI) score. [ Time Frame: Every 3 months until Year 2 ]CCI will be evaluated using the following data: morbidity, mortality.
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): NCT03073694
|Contact: Mazin Al-kasspooles, MDfirstname.lastname@example.org|
|Contact: Ashley Shoresemail@example.com|
|United States, Kansas|
|The University of Kansas Medical Center||Not yet recruiting|
|Westwood, Kansas, United States, 66205|
|Contact: Steve Williamson, MD 913-588-3808 SWILLIAM@kumc.edu|
|Principal Investigator:||Mazin Al-kasspooles, MD||The University of Kansas - Cancer Center|