Comparing two chemotherapy drugs for colorectal cancer treatment
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
This study tests which of two chemotherapy drugs, mitomycin-C or melphalan, works better and is safer for patients with colorectal cancer that has spread to the abdomen after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Westwood, Kansas) |
| Trial ID | NCT03073694 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare the safety and effectiveness of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) using two different drugs, mitomycin-C and melphalan, for patients with colorectal peritoneal carcinomatosis. The study will assess morbidity and mortality rates through various scoring systems, including the Comprehensive Complication Index and the Clavien-Dindo Classification. By evaluating these outcomes, the trial seeks to determine which chemotherapy agent provides better results for patients undergoing this treatment. Randomization will occur during surgery based on the ability to achieve complete cytoreduction.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with peritoneal surface disease due to colorectal or high-grade appendiceal cancer and no evidence of systemic metastases.
Not a fit: Patients with prior CRS-HIPEC treatment or those unable to achieve complete cytoreduction during surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with colorectal peritoneal carcinomatosis.
How similar studies have performed: Other studies have shown promising results with CRS-HIPEC, but this specific comparison of mitomycin-C versus melphalan is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria
* Ability to understand and the willingness to sign a written informed consent.
* Peritoneal Surface Disease (PSD) due to Colorectal Cancer or High-Grade Appendiceal Cancer
* No clear evidence of systemic metastases
* No prior CRS-HIPEC treatment
* Patient has a planned CC0 (Complete Macroscopic Cytoreduction (visual)) cytoreduction - NOTE: randomization occurs during surgery and not before; if, during surgery, the PI/SubI discerns that all disease cannot be removed surgically, the participant will be considered a "screen failure", HIPEC will not be performed, and the participant will be removed from the study. If participant is removed from the study, PI / surgeon will decide if standard of care surgery will proceed.
* Age 18 - 75
* ECOG (Eastern Cooperative Oncology Group) Score 0 - 2
* Recorded ASA (American Society of Anesthesiologist Classification) classification - as determined by the anesthesiologist (particular value not required - only recording of the classification is required).
* Medically fit to undergo complex major abdominal surgery, as determined by examination by PI / Sub-Is.
* Medically fit to receive systemic chemotherapy, as determined by examination by PI / Sub-Is.
* Adequate organ and marrow function as defined below:
* leukocytes ≥ 3,000/mcL (microliter)
* absolute neutrophil count ≥ 1,500/mcL
* platelets ≥ 100,000/mcL
* total bilirubin within normal institutional limits
* AST (Aspartate aminotransferase) (SGOT \[Serum Glutamic Oxaloacetic Transaminase\]) ≤ 2.5 X institutional upper limit of normal
* ALT (Alanine Aminotransferase) (SPGT \[Serum Glutamic Pyruvic Transaminase\]) ≤ 2.5 X institutional upper limit of normal
* creatinine within normal institutional limits
* Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
* Men of child-bearing potential must not donate sperm while on this study and for 90 days after the study treatment (surgery with HIPEC).
Exclusion Criteria Participants meeting any of the exclusion criteria at baseline will be excluded from study participation.
* Current or anticipated use of other investigational agents while participating in this study.
* Patient has received systemic chemotherapy or radiotherapy within 4 weeks prior to study enrollment.
* Patient has not recovered sufficiently (PI will judge patient recovery status) from adverse events due to agents administered more than 4 weeks prior to enrollment on this study.
* Patient has history of or currently has non-peritoneal surface metastatic disease in addition to peritoneal surface malignancy.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to mitomycin-C or melphalan.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, life-threatening cardiac arrhythmia, severe pulmonary disease, uncontrolled diabetes, severe kidney disease or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants.
* Patient actively being treated for other malignancy (current active treatment of early stage squamous or basal cell carcinomas of the skin is allowed, excluding treatment with other investigational agents and systemic chemotherapy or radiotherapy).
Where this trial is running
Westwood, Kansas
- The University of Kansas Medical Center — Westwood, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Mazin Al-kasspooles, MD — The University of Kansas - Cancer Center
- Study coordinator: Mazin Al-kasspooles, MD
- Email: mal-kasspooles@kumc.edu
- Phone: 913-588-6568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.