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Locally Advanced Rectal Cancer Treatment Study

Clinical Trial Title: 
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
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Ross Abrams, MD
Clinical Trial Protocol Description: 

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.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have ad iagnosis of rectal adenocarcinoma.
  • Have had no prior pelvic radiation.
  • Have a tumor that is not causing symptomatic bowel obstruction.
  • Have no previous cancer diagnosis (except colonic polyps, non-melanoma skin cancer, or carcinoma-in-situ of the cervix) ≤ 5 years prior to study registration.

This is a partial list of elgibility requirements.

Clinical Trial Area: 
Gastrointestinal Cancers
Contact Phone: 
(312) 942-0836
Contact Name: 
Adrianne Kajmowicz, RN, BSN