Study on Post-Surgery Chemotherapy Treatments for Appendix, Colon, or Rectum Cancer with Peritoneal Spread
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT01815359
This clinical trial is comparing two types of chemotherapy treatments given after surgery to remove cancer from the appendix, colon, or rectum that has spread to the lining of the abdomen. The study aims to understand the effects of these treatments on patients and their cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is the first to compare two chemotherapy methods, EPIC and HIPEC, used after surgery to remove cancer from the appendix, colon, or rectum that has spread to the abdominal lining. The goal is to see how these treatments affect patients and their cancer, both positively and negatively.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Diagnosed with cancer of the appendix or colon/rectum that has spread to the abdominal lining.
- Planning to have surgery to remove all visible cancer in the abdomen.
- In good general health, able to perform daily activities with minimal restrictions.
- Have adequate blood cell counts and organ function based on specific medical tests.
- Women of childbearing age must test negative for pregnancy and agree to use effective birth control during the study.
- Men must agree to use reliable birth control methods during the study.
- Must provide written consent to participate in the study.
- If previously diagnosed with endometrial cancer, must have had a low-stage, non-aggressive form.
Exclusion Criteria
- Have had chemotherapy directly into the abdomen before.
- Have certain types of tumors with low potential to spread.
- Have had other cancers unless they were treated and inactive for over three years.
- Cancer has spread beyond the abdomen or lymph nodes.
- Pregnant or breastfeeding women.
- Have medical conditions that prevent understanding or participating in the study.
- Have active heart disease or uncontrolled high blood pressure.
- Have severe lung disease or heart failure.
- Have had a stroke or other severe medical issues that limit participation.
- Allergic to specific chemotherapy drugs used in the study.
- Have extensive scar tissue in the abdomen that prevents treatment.
- Taking medications that cannot be safely stopped for the study.
- Have a life expectancy of less than 12 weeks.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami | Miami | Florida | |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| Memorial Sloan Kettering Basking Ridge (Consent and Follow up) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Consent and Follow up) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Consent and Follow up) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Commack (Consent and Follow up) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Consent and Follow up) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Consent and Follow up) | 11553 | Uniondale | New York |
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