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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01266 | Registry Identifier | NCI CTRP |
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The goal of this clinical research study is to find out if Xeloda® (capecitabine) and radiation therapy can help to control breast cancer that did not respond well to chemotherapy.
The safety of this study treatment will also be studied.
The Study Treatment:
Radiation therapy and capecitabine are both designed to interfere with the growth of cancer cells.
Study Therapy:
If you are found to be eligible to take part in this study, you will receive radiation therapy once or twice a day, 5 days a week, for about 5 -7 weeks. The schedule and number of weeks will be the doctor's decision based on the type of breast cancer.
The radiation treatments will take about 15-30 minutes each time.
You will take the Capecitabine pills by mouth every day during the 5-7 weeks that you receive radiation therapy. The pills should be taken 2 times a day, about 12 hours apart, 30 minutes after eating food. On the radiation therapy days, you will take capecitabine about 2 hours before the radiation therapy.
You will be given a pill diary in which you should record what time you take each dose of capecitabine.
Study Visits:
Once a week while you are receiving study treatment, you will have a physical exam.
Length of Study:
You may remain on study treatment for up to 7 weeks. You will be taken off study treatment early if the disease gets worse or intolerable side effects occur.
Based on the status of the cancer, if you become eligible to have surgery after radiation, you will be referred to a surgeon to discuss that option.
Follow-Up Visits:
At Month 3 after finishing radiation therapy (or surgery, if applicable), you will have a positron emission tomography / computed tomography (PET/CT) scan or ultrasound to check the status of the disease.
At Months 9, 17, and 29 after finishing radiation therapy or surgery, you may have a PET/CT scan, ultrasound, and/or routine blood tests if your doctor thinks it is needed. The amount of blood drawn, if any, will be the doctor's decision based on routine care.
This is an investigational study. Capecitabine is commercially available and FDA approved to treat breast cancer that has spread. Radiation therapy is also commonly used to treat breast cancer. The combination of capecitabine and radiation therapy is commonly used to treat rectal cancer.
At this time, it is considered investigational to give the combination of capecitabine and radiation therapy to patients with breast cancer.
Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy + Capecitabine | Experimental | Capecitabine 825 mg/m2 twice a day. One of the two daily doses of capecitabine should be taken approximately 2 hours before receiving radiotherapy. The first day of Capecitabine is same day that radiotherapy is started, and last day that Capecitabine is given is last day of radiotherapy. Capecitabine administered only on days patient receives radiation therapy. Radiation therapy dose 50-57 Gy to initial clinical target volume (CTV, gross disease + tissue at risk for micrometastatic disease including margin around gross disease and draining regional lymphatics). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | 50-57 Gy per faction once or twice a day, 5 days a week, for about 5 -7 weeks, about 15-30 minutes each time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy. | Participants were monitored from 2009 to 2012. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Woodward, MD, PHD | UT MD Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients who enrolled into the study and signed consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy. | All patients who received protocol - specified treatment. | Posted | Number | participants | Participants were monitored from 2009 to 2012. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Opportunistic Infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Woodward,Wendy,M.D., PH.D. | UT MD Anderson Cancer Center | 713-792-7734 | CR_Study_Registration@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2012 | May 10, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| Capecitabine | Drug | During 5-7 weeks of radiation therapy, 825 mg/m2 (pills) by mouth, 2 times a day, about 12 hours apart, 30 minutes after eating food and about 2 hours before radiation therapy. |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patients enrolled were female gender over the age of 18. | Number of patients enrolled into the protocol were eligible patients who were women over the age of 18. | Number | participants |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 18 |
| 26 |
| Muscle Weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pulmonary Inflitrates | General disorders | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Infection with Normal Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Edema, limb | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Edema, trunk | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pain: extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain: chest wall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pain: bone | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Pain: esophagus | Gastrointestinal disorders | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pain: lymph node | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Pain: skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Infection with uknown Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombus | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Vomitting | General disorders | Non-systematic Assessment |
|
| Pain: stomach | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hand/foot skin reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Diarrhea | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dehydration | Nervous system disorders | Non-systematic Assessment |
|
| Fatigue | Endocrine disorders | Non-systematic Assessment |
|
| Fibrosis Deep Connective Tissue | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Pain - Cardiac | Cardiac disorders | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |