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Radiation Therapy With Capecitabine in Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00176787
Recruitment Status : Terminated (recruitment goals met)
First Posted : September 15, 2005
Last Update Posted : January 10, 2008
Hoffmann-La Roche
Information provided by:
University of Michigan Rogel Cancer Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: Capecitabine Procedure: Radiation Procedure: Surgery Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Preoperative Radiation Therapy With Capecitabine in Rectal Cancer (UMCC 0046)
Study Start Date : October 2000
Actual Primary Completion Date : May 2005
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Objectives:
  2. In patients with locally advanced rectal cancer treated with preoperative radiation and capecitabine chemotherapy to estimate:
  3. a. the pathologic complete response rate
  4. b. the clinical response rate
  5. c. the proportion of patients converted to sphincter sparing surgery
  6. clinical response rate [ Time Frame: 2 cycles ]
  7. d. The quantitative and qualitative toxicities of the treatment approach
  8. e. The relationship of intratumoral levels of thymidylate synthase, dipyrimidine dehydrogenase and thymidine phosphorylase determined immunohistochemically to response

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00176787

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United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Hoffmann-La Roche
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Principal Investigator: Mark Zalupski, M.D. University of Michigan Rogel Cancer Center
Layout table for additonal information Identifier: NCT00176787    
Other Study ID Numbers: UMCC 0046
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 10, 2008
Last Verified: December 2007
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents