Clinical Trial

Neoadjuvant chemoradiation therapy and local excision for rectal cancer.

Protocol number: ACOSOG Z6041

Type of cancer: Stage I rectal cancer

Physician: Susan Gearhart, M. D., Surgical Oncologist

Phase number: II

General eligibility: Patients with documented rectal cancer who:
• have a tumor that is completely respectable by local excision
• have had an ultrasound or MRI revealing the cancer to be Stage I (uT2N0)
• must be in good physical condition
• have good blood counts and organ function

who haven’t had:
prior chemotherapy and/or radiation therapy for the treatment of this cancer

Purpose: The primary objective of this study is to determine the rate of disease-free survival at three years in ultrasound-staged uT2N0 rectal cancer patients treated with chemoradiation therapy followed by local excision. Disease-free survival is defined as the cancer showing no evidence of recurrence, or, distant metastasis on clinical, radiological, or ultrasound examination three years after the original ultrasound or MRI discovery of the disease.

The secondary objectives are to determine:
• the rate of respectability, with negative margins, in ultrasound-staged uT2N0 rectal cancer treated with neoadjuvant chemoradiation therapy followed by local excision
• the procedure-specific morbidity and mortality rates following neoadjuvant chemoradiation therapy and local excision
• the rate of pathologic, complete response of the primary tumor to a chemoradiation therapy regimen, which includes capecitabine plus oxaliplatin

and, to explore:
• the impact of neoadjuvant chemoradiation therapy, followed by local excision, on anorectal (both anus and rectum) function and quality of life
• the feasibility of using molecular studies to assess surgical resection of margins and tumor response to neoadjuvant chemoradiation therapy
• the molecular markers associated with local tumor recurrence

Treatment:   For Stage I (uT2N0) tumors, patients will be offered preoperative therapy with 5- FU, followed by local excision at six to eight weeks following treatment.


Jamila A. Mwidau, RN, BSN,MPH
Sr. Research Nurse/Coordinator
Tel: 410-502-2673

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