Colon and Rectal Surgery

Below are current clinical trials.

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1. Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   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 to treat patients with advanced colorectal cancer.

2. A Safety to Evaluate the Safety and Effectiveness of Pressurized Intraperitoneal Aerosolized Chemotherapy in Ovarian, Uterine, Colorectal, and Gastric Cancer Patients

   Jacksonville, Fla.

   The purpose of this study is to evaluate the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in 2 groups of patients with peritoneal carcinomatosis (PC), either due to primary ovarian, uterine, or gastric carcinoma (Arm 1) or to primary colorectal carcinoma (Arm 2), based on treatment-related adverse events reported by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.  

3. Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

   Rochester, Minn.

   The primary purpose of this study is to characterize the microbes that are causal of colorectal cancer and those that are merely conditions of the tumor. This will be accomplished by comparing the microbiomes before and after resection.

4. A Study to Investigate the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections.

    

    

5. A Study to Analyze AVB-114 to Treat Complex Crohn’s Perianal Fistulas in Subjects with Quiescent Rectal Disease

   Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

   The purpose of this study is to determine whether AVB-114 compared to standard of care treatment is effective in inducing remission of the treated complex perianal fistula in subjects with Crohn’s Disease. It also aims to assess clinical and radiologic components of fistula remission, safety of treatment, disease activity, patient Quality of Life, and patient care journey, between AVB-114 and standard of care treatment.

6. A Study to Examine Financial Distress in Patients Undergoing Treatment of Locally-advanced Rectal Cancer

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to examine the needs and gap in our understanding of financial burden experienced by rectal cancer patients from a patient perspective to help provide patient centered care and improve psychosocial outcomes of this group.