Radiation Therapy With Capecitabine in Rectal Cancer

This study has been terminated.
(recruitment goals met)
Hoffmann-La Roche
Information provided by:
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: December 28, 2007
Last verified: December 2007

September 12, 2005
December 28, 2007
October 2000
May 2005   (final data collection date for primary outcome measure)
  • Objectives:
  • In patients with locally advanced rectal cancer treated with preoperative radiation and capecitabine chemotherapy to estimate:
  • a. the pathologic complete response rate
  • b. the clinical response rate
  • c. the proportion of patients converted to sphincter sparing surgery
  • clinical response rate [ Time Frame: 2 cycles ] [ Designated as safety issue: No ]
  • d. The quantitative and qualitative toxicities of the treatment approach
  • e. The relationship of intratumoral levels of thymidylate synthase, dipyrimidine dehydrogenase and thymidine phosphorylase determined immunohistochemically to response
Same as current
Complete list of historical versions of study NCT00176787 on ClinicalTrials.gov Archive Site
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Radiation Therapy With Capecitabine in Rectal Cancer
Phase II Trial of Preoperative Radiation Therapy With Capecitabine in Rectal Cancer (UMCC 0046)

This study will use an experimental combination of treatment with the drug Capecitabine and radiation therapy prior to an operation for removal of the patient's tumor. The drug Capecitabine is an oral form of a drug called 5-FU which has been widely used to treat rectal cancer.

This is a phase II clinical trial, which means that the physician will be studying the reactions of the patient's body and tumor to treatment with Capecitabine and radiation therapy. The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. The study also will see what kind of side effects this experimental treatment causes and see how often these side effects occur.

Preliminary human studies using Capecitabine and radiation therapy have produced encouraging results with acceptable side effects.

Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Cancer
  • Drug: Capecitabine
  • Procedure: Radiation
  • Procedure: Surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2007
May 2005   (final data collection date for primary outcome measure)

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 eligible.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
UMCC 0046
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University of Michigan Cancer Center
Hoffmann-La Roche
Principal Investigator: Mark Zalupski, M.D. University of Michigan Cancer Center
University of Michigan Cancer Center
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP