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Phase II Trial of Preoperative Radiation Therapy With Capecitabine in Rectal Cancer (UMCC 0046)

Phase 2
18 Years
Not Enrolling
Rectal Cancer

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Trial Information

Phase II Trial of Preoperative Radiation Therapy With Capecitabine in Rectal Cancer (UMCC 0046)

Inclusion Criteria

Eligibility Criteria

1. Histologic confirmation of adenocarcinoma of the rectum.

2. The lesion must be located in the rectum. For purposes of this study, the lesion must
be within 12 cm of the anus as measured by sigmoidoscopy.

3. Patients must have indication of a locally advanced lesion defined for this study as
tumor through the bowel wall (> T3) or involving regional lymph nodes (>N1). Clinical
stage determination may be made by physical examination (for T4 lesions only),
endoscopic ultrasound or CT scan of pelvis.

4. Patients with metastatic disease are eligible provided operative intervention on
primary site is anticipated.

5. Patients must have adequate organ function defined as pretreatment leukocyte count >
3,000/ul, platelet count > 100,000/ul, serum creatinine < 2.0 mg/dl, serum bilirubin
< 2 mg/dl. Note: Capecitabine is contraindicated in patients with severe renal
impairment (creatinine clearance < 30 ml/min). In patients with calculated creatinine
clearance of 30-50 ml/min capecitabine will begin at (-)1 level dose reduction (see
section 6.3)

6. Patients must be at least 18 years of age and have a Zubrod performance status of < 2
(see appendix 1.)

7. Patients must be informed of the investigational nature of this study and provide
written informed consent in accordance with institutional and federal guidelines
prior to the initiation of therapy.

Exclusion Criteria:

1. Patients may not have received previous pelvic irradiation for any indication, or
previous chemotherapy for cancer therapy within the preceding 6 months.

2. Patients must have no other serious medical or psychiatric illness that would limit
the ability of the patient to receive protocol therapy or provide informed consent.

3. Pregnant or lactating women may not participate. Women/men of reproductive potential
must agree to use an effective contraceptive method.

4. Patients with lack of physical integrity of the upper gastrointestinal tract,
inability to swallow tablets or those who have malabsorption syndrome are not

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Principal Investigator

Mark Zalupski, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Food and Drug Administration

Study ID:

UMCC 0046



Start Date:

October 2000

Completion Date:

June 2007

Related Keywords:

  • Rectal Cancer
  • Rectal Neoplasms



University of Michigan Cancer Center Ann Arbor, Michigan  48109