Trial Outcomes & Findings for Xeloda (Capecitabine) and External Beam Radiation (NCT NCT00916578)
NCT ID: NCT00916578
Last Updated: 2018-07-26
Results Overview
The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Participants were monitored from 2009 to 2012.
Results posted on
2018-07-26
Participant Flow
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Insurance Denial
|
2
|
Baseline Characteristics
Xeloda (Capecitabine) and External Beam Radiation
Baseline characteristics by cohort
| Measure |
Single Arm Institution, Open Label, Phase II
n=33 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 12.02326 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
1 participants
n=5 Participants
|
|
Patients enrolled were female gender over the age of 18.
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were monitored from 2009 to 2012.Population: All patients who received protocol - specified treatment.
The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy.
Outcome measures
| Measure |
Single Arm Institution, Open Label, Phase II
n=33 Participants
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.
|
|---|---|
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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.
|
26 participants
|
Adverse Events
Single Arm Institution, Open Label, Phase II
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm Institution, Open Label, Phase II
n=26 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytes
|
7.7%
2/26 • 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 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.
|
|
Blood and lymphatic system disorders
Infection with Normal Neutropenia
|
11.5%
3/26 • 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 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.
|
|
Musculoskeletal and connective tissue disorders
Edema, limb
|
11.5%
3/26 • 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 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.
|
|
Musculoskeletal and connective tissue disorders
Edema, trunk
|
11.5%
3/26 • 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 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.
|
|
Musculoskeletal and connective tissue disorders
Pain: extremity
|
15.4%
4/26 • 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 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.
|
|
Infections and infestations
Opportunistic Infection
|
3.8%
1/26 • 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 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
3.8%
1/26 • 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 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.
|
|
General disorders
Pulmonary Inflitrates
|
3.8%
1/26 • 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 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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.7%
2/26 • 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 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.
|
|
Musculoskeletal and connective tissue disorders
Pain: chest wall
|
11.5%
3/26 • 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 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.5%
3/26 • 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 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.
|
|
Musculoskeletal and connective tissue disorders
Pain: bone
|
11.5%
3/26 • 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 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.
|
|
General disorders
Nausea
|
15.4%
4/26 • 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 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.
|
|
Gastrointestinal disorders
Pain: esophagus
|
15.4%
4/26 • 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 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.
|
|
Gastrointestinal disorders
Esophagitis
|
15.4%
4/26 • 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 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.
|
|
Blood and lymphatic system disorders
Pain: lymph node
|
15.4%
4/26 • 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 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.
|
|
Skin and subcutaneous tissue disorders
Pain: skin
|
19.2%
5/26 • 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 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.
|
|
Blood and lymphatic system disorders
Infection with uknown Neutropenia
|
19.2%
5/26 • 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 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.
|
|
Blood and lymphatic system disorders
Thrombus
|
23.1%
6/26 • 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 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.
|
|
General disorders
Vomitting
|
26.9%
7/26 • 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 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.
|
|
Gastrointestinal disorders
Pain: stomach
|
26.9%
7/26 • 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 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.
|
|
Skin and subcutaneous tissue disorders
Hand/foot skin reaction
|
23.1%
6/26 • 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 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.
|
|
Metabolism and nutrition disorders
Diarrhea
|
3.8%
1/26 • 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 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.
|
|
Nervous system disorders
Dehydration
|
7.7%
2/26 • 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 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.
|
|
Endocrine disorders
Fatigue
|
3.8%
1/26 • 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 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.
|
|
Blood and lymphatic system disorders
Fibrosis Deep Connective Tissue
|
3.8%
1/26 • 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 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.
|
|
Cardiac disorders
Pain - Cardiac
|
3.8%
1/26 • 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 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.
|
Additional Information
Woodward,Wendy,M.D., PH.D.
UT MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place