Radiation Therapy With Capecitabine in Rectal Cancer

Tracking Information
First Submitted Date ICMJE	September 12, 2005
First Posted Date ICMJE	September 15, 2005
Last Update Posted Date	January 10, 2008
Study Start Date ICMJE	October 2000
Actual Primary Completion Date	May 2005 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 28, 2007)	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 ]; 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
Original Primary Outcome Measures ICMJE; (submitted: September 12, 2005)	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; 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
Change History	Complete list of historical versions of study NCT00176787 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Radiation Therapy With Capecitabine in Rectal Cancer
Official Title ICMJE	Phase II Trial of Preoperative Radiation Therapy With Capecitabine in Rectal Cancer (UMCC 0046)
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Rectal Cancer
Intervention ICMJE	Drug: Capecitabine; Procedure: Radiation; Procedure: Surgery
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Enrollment ICMJE; (submitted: September 12, 2005)	30
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	June 2007
Actual Primary Completion Date	May 2005 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Eligibility Criteria; Histologic confirmation of adenocarcinoma of the rectum.; 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.; 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.; Patients with metastatic disease are eligible provided operative intervention on primary site is anticipated.; 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); Patients must be at least 18 years of age and have a Zubrod performance status of < 2 (see appendix 1.); 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: 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00176787
Other Study ID Numbers ICMJE	UMCC 0046
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	University of Michigan Cancer Center
Collaborators ICMJE	Hoffmann-La Roche
Investigators ICMJE	Principal Investigator: Mark Zalupski, M.D. University of Michigan Cancer Center
PRS Account	University of Michigan Cancer Center
Verification Date	December 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP