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Alkylating agents

CRS-HIPEC for Colorectal Cancer

Phase 2

Recruiting

Led By Mazin Al-kasspooles, MD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Peritoneal Surface Disease (PSD) due to Colorectal Cancer or High-Grade Appendiceal Cancer

ECOG Score 0 - 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 3 months until year 2

Awards & highlights

Study Summary

This trial is comparing two different treatments for a type of cancer that has spread to the abdomen. The goal is to see which treatment results in fewer complications and side effects.

Who is the study for?

This trial is for adults aged 18-75 with colorectal cancer or high-grade appendiceal cancer that hasn't spread beyond the peritoneum. They must be medically fit for major surgery and chemotherapy, have good organ function, and agree to use contraception. Exclusions include other active cancers, recent chemo or radiotherapy, severe illnesses, pregnancy/nursing, or allergies to study drugs.Check my eligibility

What is being tested?

The trial compares two types of chemotherapy (mitomycin-C vs melphalan) used during a surgical procedure called CRS-HIPEC in patients with specific abdominal cancers. The focus is on assessing complications and side effects using various medical scores like CCI and CTCAE.See study design

What are the potential side effects?

Potential side effects from mitomycin-C or melphalan may include damage to white blood cells leading to increased infection risk, anemia due to low red blood cell count, bleeding issues from low platelets, liver problems indicated by bilirubin levels changes; fatigue; nausea; kidney function impairment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is due to cancer in my appendix or colon that has spread to the lining of my abdomen.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I am healthy enough to undergo chemotherapy.

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I have never had CRS-HIPEC treatment.

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I am scheduled for a surgery aiming for no visible cancer.

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I am healthy enough for major abdominal surgery.

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My cancer has not spread to other parts of my body.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 3 months until year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 3 months until year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months until year 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comprehensive Complication Index (CCI) score.

Side effects data

From 2021 Phase 3 trial • 30 Patients • NCT01877837

36%

Infection (grade 3 and above)

24%

Graft versus host disease

Renal insufficiency

SupraVentricular Tachycardia

Alerted mental status

Posterior Reversible Encephalopathy Syndrome

Gastrointestinal bleed

Respiratory failure

Hypokalemia

100%

80%

60%

40%

20%

Study treatment Arm

Patients With Sickle Cell Anemia

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Melphalan GroupExperimental Treatment1 Intervention

Melphalan 60 mg/m2 (milligrams per meter squared) 45 minutes into the perfusion.

Group II: Mitomycin C GroupActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melphalan

2008

Completed Phase 3

~1500

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

463 Previous Clinical Trials

169,169 Total Patients Enrolled

Mazin Al-kasspooles, MDPrincipal InvestigatorThe University of Kansas - Cancer Center

Media Library

Melphalan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03073694 — Phase 2

Appendiceal Cancer Research Study Groups: Melphalan Group, Mitomycin C Group

Appendiceal Cancer Clinical Trial 2023: Melphalan Highlights & Side Effects. Trial Name: NCT03073694 — Phase 2

Melphalan (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03073694 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment of participants in this experiment?

"Affirmative. Per the data presented on clinicaltrials.gov, recruitment for this trial is currently ongoing; commencing 14th July 2017 and recently revised 6th June 2022. The study has a target of recruiting 100 individuals at one location."

Answered by AI

Is the enrollment process for this trial still ongoing?

"Per the data accessible via clinicaltrials.gov, this medical trial is actively looking for enrollees. It was first announced on July 14th 2017 and its most recent update came on June 6th 2022."

Answered by AI

Could individuals under the age of fifty partake in this clinical trial?

"This clinical trial is designed for patients between the ages of 18 and 75. Conversely, 153 studies are available to those under 18 years old and 2,687 research projects have been set up for participants above 65."

Answered by AI

What kind of participants are eligible to join this medical trial?

"This research team needs 100 individuals, aged 18 to 75, who have been diagnosed with appendiceal cancer. Additionally, each participant must be medically able to handle the complexities of major abdominal surgery (as determined by the PI/Sub-Is), not show signs of metastasis or prior CRS-HIPEC treatment, and their ASA classification should be noted by anesthesiologist. The randomization process begins during operation; if a complete cytoreduction is deemed impossible at that point in time then they will no longer qualify for this trial and alternative medical care may take its place."

Answered by AI

For which conditions is Melphalan regularly employed?

"Melphalan is the go-to medication for treating cervical cancers. It has also been known to be effective in managing lg-utuc, glaucoma, and amyloidosis."

Answered by AI

What deleterious effects can arise from the use of Melphalan?

"The Power team has assessed Melphalan's safety as a 2 on their scale, due to the lack of clinical data verifying its efficacy. However, there is evidence that it could be safe for human use."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC) Using Mitomycin-C Versus Melphalan for Colorectal Peritoneal Carcinomatosis

2017. "Comparing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC) Using Mitomycin-C Versus Melphalan for Colorectal Peritoneal Carcinomatosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03073694.

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