A Phase II Study of Chemotherapy and Chemoradiation Followed by Surgery or Non-Operative Management in Patients with Stage II or III Rectal Cancer

Protocol
13-213
Full Title
A Phase II Multicenter Randomized Trial Evaluating 3-year Disease Free Survival in Patients with Locally Advanced Rectal Cancer Treated with Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management
Phase
II
Purpose

The standard treatment for stage II/III rectal cancer is chemotherapy and radiation therapy (“chemoradiation”) followed by surgery to remove the rectum. Patients may have additional chemotherapy given after surgery to further reduce their risk of cancer recurrence and to increase the rate of response of the primary tumor.

In this study, researchers want to see if giving the additional chemotherapy before surgery, before or after the chemoradiation, is more effective than the standard treatment for patients with previously untreated stage II or III rectal cancer, and if it may even be able to spare some patients from surgery to remove the rectum. Patients in this study will be randomly assigned to receive chemotherapy followed by chemoradiation, or chemoradiation followed by chemotherapy.

Patients whose tumors disappear with either approach will not have surgery and will be monitored. Patients whose tumors did not respond significantly to chemotherapy and chemoradiation will go on to have rectal surgery.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage II or stage III rectal cancer.
  • Patients may not have received prior chemotherapy or surgery for rectal cancer, nor any previous pelvic radiation therapy.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Julio Garcia-Aguilar at 212-639-5117.

Disease(s)
Colorectal Cancer: Rectal Cancer
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