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Trial record 61 of 1643 for:    Slovakia

A Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal Cancer

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ClinicalTrials.gov Identifier: NCT00796718
Recruitment Status : Completed
First Posted : November 24, 2008
Results First Posted : August 25, 2016
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Radiation: Standard radiotherapy
Drug: Capecitabine [Xeloda]
Enrollment 62
Recruitment Details  
Pre-assignment Details A total of 62 participants were enrolled in the study.
Arm/Group Title Capecitabine
Hide Arm/Group Description Capecitabine 825 milligrams per meter square (mg/m^2) orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
Period Title: Overall Study
Started 62
Completed 53
Not Completed 9
Reason Not Completed
Adverse Event             2
Exclusion Criteria             1
Lost to Follow-up             5
Withdrawal by Informed Consent             1
Arm/Group Title Capecitabine
Hide Arm/Group Description Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
Overall Number of Baseline Participants 62
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants
59.0  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
Female
22
  35.5%
Male
40
  64.5%
1.Primary Outcome
Title Percentage of Participants With Pathological Complete Response
Hide Description Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures.
Time Frame Up to 11 weeks (assessed at the time of post-treatment surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data.
Arm/Group Title Capecitabine
Hide Arm/Group Description:
Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
16
2.Secondary Outcome
Title Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)
Hide Description Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.
Time Frame Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data.
Arm/Group Title Capecitabine
Hide Arm/Group Description:
Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of participants
Complete Response 2
Partial Remission 12.2
No Response 77.6
3.Secondary Outcome
Title Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)
Hide Description Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.
Time Frame Up to 15 weeks (assessed 1 month after surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data.
Arm/Group Title Capecitabine
Hide Arm/Group Description:
Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
Complete Response 56
Partial Remission 10
No Response 14
4.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An adverse event was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.
Time Frame Up to 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Capecitabine
Hide Arm/Group Description:
Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: percentage of participants
91.9
Time Frame Up to 15 weeks
Adverse Event Reporting Description All enrolled participants.
 
Arm/Group Title Capecitabine
Hide Arm/Group Description Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
All-Cause Mortality
Capecitabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine
Affected / at Risk (%)
Total   4/62 (6.45%) 
Cardiac disorders   
Ventricular fibrillation  1  1/62 (1.61%) 
Gastrointestinal disorders   
Diarrhea  1  2/62 (3.23%) 
Hemorrhoidal inflammation  1  1/62 (1.61%) 
Ileus  1  1/62 (1.61%) 
Infections and infestations   
Sepsis  1  1/62 (1.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Capecitabine
Affected / at Risk (%)
Total   49/62 (79.03%) 
Blood and lymphatic system disorders   
Anemia  1  4/62 (6.45%) 
Leukopenia  1  8/62 (12.90%) 
Neutropenia  1  5/62 (8.06%) 
Gastrointestinal disorders   
Abdominal pain  1  8/62 (12.90%) 
Diarrhea  1  21/62 (33.87%) 
Nausea  1  7/62 (11.29%) 
Rectal pain  1  12/62 (19.35%) 
General disorders   
Fatigue  1  6/62 (9.68%) 
Infections and infestations   
Upper respiratory infection  1  4/62 (6.45%) 
Injury, poisoning and procedural complications   
Dermatitis radiation  1  20/62 (32.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cyst in the liver  1  4/62 (6.45%) 
Skin and subcutaneous tissue disorders   
Erythema  1  4/62 (6.45%) 
Palmar-plantar erythrodysesthesia syndrome  1  4/62 (6.45%) 
Vascular disorders   
Hypertension  1  4/62 (6.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00796718     History of Changes
Other Study ID Numbers: ML21800
2008-003980-38
First Submitted: November 21, 2008
First Posted: November 24, 2008
Results First Submitted: July 14, 2016
Results First Posted: August 25, 2016
Last Update Posted: August 25, 2016