Inclusion Criteria:

1. Patients with measurable disease, medically able to undergo pelvic surgery.

2. Patients with unresectable adenocarcinoma of the rectum located up to 12 cm from the
anal verge without evidence of distant metastases.

3. Patients must be 18 years old or greater.

4. Patients with clinical stage T3 orT4 based on endorectal ultrasound or physical exam.

5. Patients with lab values within standard protocol parameters

6. Karnofsky performance status > 60.

7. No history of other malignancies within 5 years, except non-melanoma skin cancer, in
situ carcinoma of the cervix or ductal carcinoma of the breast. Previous invasive
cancer permitted if disease-free at least 5 years

8. Patient must sign study-specific consent prior to randomization.

Exclusion Criteria:

1. Any evidence of distant metastasis

2. Synchronous primary colon carcinomas, except T1 lesions

3. Prior radiation therapy to the pelvis

4. Prior chemotherapy for malignancies

5. Pregnancy or lactation.

6. Serious, uncontrolled, concurrent infection(s).

7. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic
coronary artery disease and cardiac arrhythmias not well controlled with medication)
or myocardial infarction within the last 12 months.

8. Evidence of uncontrolled seizures, central nervous system disorders or psychiatric
disability judged by the investigator to be clinically significant, precluding
informed consent, or interfering with compliance of oral drug intake.

9. Other serious uncontrolled medical conditions that the investigator feels might
compromise study participation.

10. Major surgery within 4 weeks of the study treatment.

11. Lack of physical integrity of the upper gastrointestinal tract or mal-absorption
syndrome.