Study on 3-Year Disease-Free Survival in Patients with Locally Advanced Rectal Cancer Treated with Chemoradiation and Surgery or Non-Surgical Management
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT02008656
This clinical trial is investigating whether patients with locally advanced rectal cancer have better outcomes when treated with a combination of chemoradiation and either surgery or non-surgical management, compared to traditional treatments.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to determine if patients with locally advanced rectal cancer have improved disease-free survival over three years when treated with a combination of chemoradiation and either surgery or non-surgical management. This approach is compared to the standard treatment of chemoradiation followed by surgery and additional chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with adenocarcinoma of the rectum.
- Cancer is at Stage II or III based on MRI results.
- Tumor requires complete surgical removal.
- No signs of cancer spread to other parts of the body.
- No previous radiation therapy to the pelvic area.
- No prior chemotherapy or surgery for rectal cancer.
- Age 18 or older (19 in some Canadian provinces).
- No active infections needing systemic antibiotics (oral antibiotics may be allowed).
- Good overall health with an ECOG performance status of 0 to 2.
- Women of childbearing potential must test negative for pregnancy and agree to use effective birth control.
- Must be able to read, agree to, and sign an informed consent form.
- Meet specific blood test criteria for white blood cells, hemoglobin, platelets, and liver function.
Exclusion Criteria
- Recurrent rectal cancer.
- Tumors that cannot be surgically removed.
- High creatinine levels indicating kidney issues.
- Previous pelvic radiation therapy.
- Inability to undergo an MRI.
- Recent history of arterial blood clots or heart-related events.
- History of blood clots more than six months ago may be eligible if on stable anticoagulant therapy.
- Cannot receive other cancer treatments or experimental therapies during the study.
- Women who are pregnant, breastfeeding, or not using effective birth control.
- Other medical or psychiatric conditions that may interfere with the study.
- History of another cancer within the past five years, except for certain skin or cervical cancers.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, Irvine | 92697 | Irvine | California |
| St. Joseph Hospital | 92868-3849 | Orange | California |
| University of California San Francisco | 94143 | San Francisco | California |
| John Muir Health | 94598 | Walnut Creek | California |
| University of Colorado | 80045 | Aurora | Colorado |
| Washington Hospital Center | 20010 | Washington D.C. | District of Columbia |
| University Of South Florida | 33620 | Tampa | Florida |
| Cleveland Clinic Florida | 33331 | Weston | Florida |
| University of Chicago | 60637 | Chicago | Illinois |
| University of Michigan | 48168 | Northville | Michigan |
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