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Clinical Trials

Gastrointestinal Protocols (colon, rectum, pancreas)

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

1.  RTOG 0848:   A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma 

The standard treatment for patients with pancreatic cancer that was removed by surgery is to receive the chemotherapy drug gemcitabine. In this study, you will get either gemcitabine alone or gemcitabine combined with erlotinib.  Erlotinib is a pill that may help treat cancers by blocking a gene that is important in cancer growth.

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.

5.  CALGB 80803:  A Randomized Phase II Trial of Pet Scan-Directed Combined Modality Therapy in Esophageal Cancer

The purpose of this trial is to learn if we can improve the outcomes for patients with esophageal cancer by using PET/CT scans to determine whether or not a particular chemotherapy regimen is showing any effect on the tumor. We are trying to learn if PET/CT response can be used as a way to better direct therapy for your tumor. 

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
845-333-1000

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Orange Regional Medical Pavilion
75 Crystal Run Road
Middletown, NY 10940
845-695-5800

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