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Clinical Trials

Gastrointestinal Protocols (colon, rectum, pancreas)

Please check with your physician for additional protocols and/or information.

1.  S1406:   A Randomized Phase II Study of Irinotecan & Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer

The purpose of this screening step is to perform a genetic test on your colorectal cancer tumor sample to see if it has a specific genetic mutation called BRAF.  BRAF is a human gene that makes a protein called B-raf.  This protein is involved in sending signals to the cells which direct cell growth. BRAF tumor testing is common for this type of cancer. The performance of the test is not part of the research question in this study. If your tissue has a BRAF mutation, you will be eligible to participate in the next part of the study.

2.  RTOG 1010:  A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment Of HER2-Overexpressing Esophageal Adenocarcinoma

This study is being done to compare the effects, good and/or bad, of the addition of trastuzumab to standard chemotherapy, radiation, and surgery for patients with HER2 positive esophageal cancer.

3.  N0148:  A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation vs. Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision

The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery.   Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit.   The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX.   The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely since 2002 to treat patients with advanced colorectal cancer.  

4.  CALGB 80802:  A Phase III Randomized Study of Sorafenib + Doxorubicin vs Sorafenib in Patients with Advanced Hepatocellular Carcinoma

The purpose of this study is to compare the effects (good and bad) of the drug sorafenib with the combination of sorafenib plus doxorubicin on you and your advanced primary liver cancer to find out which is better. In this study, you will get either the combination of sorafenib plus doxorubicin or you will receive sorafenib alone. At the present time, sorafenib is approved by the Food and Drug Administration (FDA) for the treatment of hepatocellular carcinoma. Doxorubicin is a marketed drug. It has been used in the treatment of a lot of different cancers, including hepatocellular cancer, but is not specifically FDA approved for hepatocellular cancer. The use of the combination of sorafenib and doxorubicin is not approved by the FDA for hepatocellular carcinoma. 

For more information on these protocols or any other research, please contact your physician or our clinical research coordinator, Jessica Gerlach, CCRP at 845-333-1133.

Orange Regional
Medical Center

707 East Main Street
Middletown, NY 10940
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Orange Regional Medical
Group - Middletown

707 East Main Street
Middletown, NY 10940

Orange Regional Medical
Group - Monroe

475 Route 17M
Monroe, NY 10950

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