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Trial record 25 of 131 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
Enrollment 33

Recruitment Details 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  
Arm/Group Title Single Arm Institution, Open Label, Phase II
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 33
Completed 26
Not Completed 7
Reason Not Completed
Physician Decision             2
Withdrawal by Subject             3
Insurance Denial             2
Arm/Group Title Single Arm Institution, Open Label, Phase II
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
Patients who enrolled into the study and signed consent.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  18.2%
>=65 years
27
  81.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
49  (12.02326)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
33
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Hispanic or Latino
4
  12.1%
Not Hispanic or Latino
29
  87.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
United States 30
Hungary 1
Puerto Rico 1
Norway 1
Patients enrolled were female gender over the age of 18.   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
33
[1]
Measure Description: Number of patients enrolled into the protocol were eligible patients who were women over the age of 18.
1.Primary Outcome
Title 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.
Hide Description The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy.
Time Frame Participants were monitored from 2009 to 2012.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who received protocol - specified treatment.
Arm/Group Title Single Arm Institution, Open Label, Phase II
Hide Arm/Group Description:
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. Radiation therapy doses will be 50-57 Gy to the initial clinical target volume.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: participants
26
Time Frame Subjects will be followed ever 3 months (+/- 1 mo) post-treatment times 1, then every 6 months (+/- 1 mo) times 1, then every 12 months (+/- 2 mos) times 2, up to 3 years
Adverse Event Reporting Description Adverse Events were collected on an excel spreadsheet which captured the start date of the AEs, the description of the AEs and the grade of the AEs.
 
Arm/Group Title Single Arm Institution, Open Label, Phase II
Hide Arm/Group Description 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.
All-Cause Mortality
Single Arm Institution, Open Label, Phase II
Affected / at Risk (%)
Total   0/26 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm Institution, Open Label, Phase II
Affected / at Risk (%)
Total   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Single Arm Institution, Open Label, Phase II
Affected / at Risk (%)
Total   18/26 (69.23%) 
Blood and lymphatic system disorders   
Neutropenia *  2/26 (7.69%) 
Leukocytes *  2/26 (7.69%) 
Infection with Normal Neutropenia *  3/26 (11.54%) 
Pain: lymph node *  4/26 (15.38%) 
Infection with uknown Neutropenia *  5/26 (19.23%) 
Thrombus *  6/26 (23.08%) 
Fibrosis Deep Connective Tissue *  1/26 (3.85%) 
Cardiac disorders   
Pain - Cardiac *  1/26 (3.85%) 
Endocrine disorders   
Fatigue *  1/26 (3.85%) 
Gastrointestinal disorders   
Pain: esophagus *  4/26 (15.38%) 
Esophagitis *  4/26 (15.38%) 
Pain: stomach *  7/26 (26.92%) 
General disorders   
Pulmonary Inflitrates *  1/26 (3.85%) 
Nausea *  4/26 (15.38%) 
Vomitting *  7/26 (26.92%) 
Infections and infestations   
Opportunistic Infection *  1/26 (3.85%) 
Metabolism and nutrition disorders   
Diarrhea *  1/26 (3.85%) 
Musculoskeletal and connective tissue disorders   
Muscle Weakness *  1/26 (3.85%) 
Edema, limb *  3/26 (11.54%) 
Edema, trunk *  3/26 (11.54%) 
Pain: extremity *  4/26 (15.38%) 
Pain: chest wall *  3/26 (11.54%) 
Pain: bone *  3/26 (11.54%) 
Nervous system disorders   
Dehydration *  2/26 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea *  3/26 (11.54%) 
Skin and subcutaneous tissue disorders   
Pain: skin *  5/26 (19.23%) 
Hand/foot skin reaction *  6/26 (23.08%) 
*
Indicates events were collected by non-systematic assessment
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
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