A Phase II Study For Patients With Advanced Rectal Cancer Using Pre-Operative High Dose Rate Brachytherapy + Folfox Chemotherapy

Summary:
Standard treatment for rectum cancer is a pre-surgery course of external beam radiotherapy given with chemotherapy at the same time. External beam radiation can increase side effects both short and long-term by exposing normal tissue nearby the tumor such as the bladder, bowel and sexual organs.  Instead, this study will use a different way of delivering radiation called brachytherapy to decrease normal tissue radiation exposure. You will be given three chemotherapy medications both before and after your surgery: oxaliplatin (also called EloxatinTM) in combination with 5-fluorouracil (5-FU) and leucovorin (also called Folinic Acid).

The purpose of this study is to find out whether giving chemotherapy and brachytherapy before surgery can: 1) enable your surgeon to successfully remove your tumor 2) lower the risk of tumor recurrence 3) avoid you having the side effects related to chemotherapy and external beam radiation therapy and 4) improve your ability to complete chemotherapy. 

Eligibility and Treatment Plan:

• Male and female of at least 18 years old
• Adenocarcinoma of the rectum
• Tumor of less than 3.5cm thickness documented at the CT Simulator
• No previous history of pelvic radiation or chemotherapy
• Use of any investigational agent within the 4 weeks preceding enrollment

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