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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

Must not have

Active treatment for other malignancy

Recent systemic chemotherapy or radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 3 months until year 2

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for another cancer.

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I have recently undergone chemotherapy or radiotherapy.

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My cancer has spread beyond the lining of my abdomen.

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I do not have any uncontrolled illnesses.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 12Eligibility criteria met