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Trial record 25 of 129 for:    inflammatory breast cancer AND Cancer Center

Xeloda (Capecitabine) and External Beam Radiation

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ClinicalTrials.gov Identifier: NCT00916578
Recruitment Status : Completed
First Posted : June 9, 2009
Results First Posted : June 28, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Radiation: Radiation Therapy
Drug: Capecitabine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Primary objective is to determine the rate of responses by RECIST criteria in all patients who received treatment that includes pre-operative or palliative concurrent radiation with capecitabine to the breast and at risk or involved regional lymph node basins. The recruitment process was located at MD Anderson Cancer Center between 2009 to 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Single Arm Institution, Open Label, Phase II The protocol was a Single Arm study in which eligible patients were women with a diagnosis of invasive breast cancer with primary or recurrent gross disease in the breast or chest wall or lymph nodes that is progressive, persistent, or minimally responsive to chemotherapy. Patients will received 825 mg/m2 bid of capecitabine. One of the two daily doses of capecitabine will be taken 2 hours before receiving radiotherapy. Capecitabine will be administered when patients receives radiation therapy. Traditional therapy dosage will be 50-57 GY to the initial clinical target volume.

Participant Flow:   Overall Study
    Single Arm Institution, Open Label, Phase II
STARTED   33 
COMPLETED   26 
NOT COMPLETED   7 
Physician Decision                2 
Withdrawal by Subject                3 
Insurance Denial                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who enrolled into the study and signed consent.

Reporting Groups
  Description
Single Arm Institution, Open Label, Phase II The protocol was a Single Arm study in which eligible patients were women with a diagnosis of invasive breast cancer with primary or recurrent gross disease in the breast or chest wall or lymph nodes that is progressive, persistent, or minimally responsive to chemotherapy. Patients will received 825 mg/m2 bid of capecitabine. One of the two daily doses of capecitabine will be taken 2 hours before receiving radiotherapy. Capecitabine will be administered when patients receives radiation therapy. Tradition therapy does will be 50-57 Gy to the initial clinical target volume.

Baseline Measures
   Single Arm Institution, Open Label, Phase II 
Overall Participants Analyzed 
[Units: Participants]
 33 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      6  18.2% 
>=65 years      27  81.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (12.02326) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      33 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      4  12.1% 
Not Hispanic or Latino      29  87.9% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   3.0% 
Asian      1   3.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      5  15.2% 
White      25  75.8% 
More than one race      0   0.0% 
Unknown or Not Reported      1   3.0% 
Region of Enrollment 
[Units: Participants]
 
United States   30 
Hungary   1 
Puerto Rico   1 
Norway   1 
Patients enrolled were female gender over the age of 18. [1] 
[Units: Participants]
 33 
[1] Number of patients enrolled into the protocol were eligible patients who were women over the age of 18.


  Outcome Measures

1.  Primary:   Response Rate of Patients Who Receive Pre-operative or Palliative Concurrent Radiation w/ Capecitabine to the Breast & at Risk or Involved Regional Lymph Nodes Basins.   [ Time Frame: Participants were monitored from 2009 to 2012. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Woodward,Wendy,M.D., PH.D.
Organization: UT MD Anderson Cancer Center
phone: 713-792-7734
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00916578     History of Changes
Other Study ID Numbers: 2009-0087
NCI-2012-01266 ( Registry Identifier: NCI CTRP )
First Submitted: June 5, 2009
First Posted: June 9, 2009
Results First Submitted: May 15, 2018
Results First Posted: June 28, 2018
Last Update Posted: July 25, 2018