Radiation Therapy With Capecitabine in Rectal Cancer

NCT00176787 | Terminated Phase 2

• 1 other identifier: UMCC 0046
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (8)

• 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

  2 cycles

• 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

Interventions

Capecitabine DRUG

Radiation PROCEDURE

Surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients may not have received previous pelvic irradiation for any indication, or previous chemotherapy for cancer therapy within the preceding 6 months.
• 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.
• Pregnant or lactating women may not participate. Women/men of reproductive potential must agree to use an effective contraceptive method.
• Patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome are not eligible.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine; Radiation; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Physical Phenomena

Study Officials

• Mark Zalupski, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: October 1, 2000
• Primary Completion: May 1, 2005
• Study Completion: June 1, 2007
• Last Updated: January 10, 2008

Record last verified: 2007-12

Locations

US (1)