Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-04-14 @ 12:26 AM
Study NCT ID:
NCT00562718
Status:
COMPLETED
Last Update Posted:
2020-08-21
First Post:
2007-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Capecitabine and Radiation Therapy in Treating Patients With Nonmetastatic Breast Cancer After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ResearchRegistry@utsouthwestern.edu', 'phone': '(214) 648-3111', 'title': 'ann spangler', 'organization': 'UT Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Surgery and Chemotherapy', 'description': 'Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.\n\ncapecitabine\n\nadjuvant therapy\n\nradiation therapy', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 8, 'seriousNumAtRisk': 39, 'deathsNumAffected': 6, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Radiation Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgery and Chemotherapy', 'description': 'Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.\n\ncapecitabine\n\nadjuvant therapy\n\nradiation therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Primarily Grade 1 and 2 toxicities attributable to capecitabine', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Radiation given based on planned- 50.4cGy'}, {'type': 'SECONDARY', 'title': 'Cosmesis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgery and Chemotherapy', 'description': 'Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.\n\ncapecitabine\n\nadjuvant therapy\n\nradiation therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgery and Chemotherapy', 'description': 'Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.\n\ncapecitabine\n\nadjuvant therapy\n\nradiation therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'This population has aggressive disease with a high rate of recurrence and death within 1 year of completing radiation therapy', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Surgery and Chemotherapy', 'description': 'Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.\n\ncapecitabine\n\nadjuvant therapy\n\nradiation therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'not stated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Surgery and Chemotherapy', 'description': 'Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.\n\ncapecitabine\n\nadjuvant therapy\n\nradiation therapy'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'masectomy', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'partial masectomy', 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'neo-adjuvant', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'adjuvant', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-19', 'studyFirstSubmitDate': '2007-11-21', 'resultsFirstSubmitDate': '2019-05-16', 'studyFirstSubmitQcDate': '2007-11-21', 'lastUpdatePostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-18', 'studyFirstPostDateStruct': {'date': '2007-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Safety', 'timeFrame': '1 year', 'description': 'Primarily Grade 1 and 2 toxicities attributable to capecitabine'}], 'secondaryOutcomes': [{'measure': 'Cosmesis', 'timeFrame': '1 year'}, {'measure': 'Recurrence', 'timeFrame': '1 year', 'description': 'This population has aggressive disease with a high rate of recurrence and death within 1 year of completing radiation therapy'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'male breast cancer', 'recurrent breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy. Giving radiation together with capecitabine after surgery may kill any remaining tumor cells.\n\nPURPOSE: This phase II trial is studying the side effects and how well giving capecitabine together with radiation therapy works in treating patients with nonmetastatic breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To determine the safety and feasibility of concurrent capecitabine and standard external-beam irradiation in patients with high-risk early stage breast cancer.\n\nSecondary\n\n* To determine the effects of concurrent treatment on cosmesis and wound healing at 1 year.\n* To determine the short-term (1-year) risk of recurrence of breast cancer in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients undergo external-beam radiotherapy once daily, 5 days a week and concurrently receive oral capecitabine twice daily, 5 days a week Monday through Friday, for approximately 6-7 weeks.\n\nAfter completion of study therapy, patients are followed at approximately 1 week, 1 month, 6 months, and 12 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female only study', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed invasive adenocarcinoma of the breast, meeting 1 of the following high-risk criteria:\n\n * T3 or T4 primary tumor\n * 4 or more involved axillary lymph nodes (N2 nodal stage)\n* Completed surgical excision\n\n * No immediate reconstruction with autologous flap reconstruction\n\n * Patients having tissue expanders or implants placed prior to radiation may be enrolled at the physician's discretion\n* No residual breast cancer\n\n * Microscopically positive margins are allowed if a re-excision is not felt to be clinically justified\n* Candidate for radiotherapy\n\n * Must not require bilateral radiotherapy\n* No metastatic (stage IV) breast cancer by AJCC staging criteria\n* Hormone receptor status not specified\n* No CNS disorders\n\nPATIENT CHARACTERISTICS:\n\n* Life expectancy ≥ 6 months\n* Karnofsky performance status 70-100%\n* Menopausal status not specified\n* Ambulatory\n* Hemoglobin \\> 9 g/dL\n* Platelet count \\> 100,000/mm³\n* ANC \\> 1,500/mm³\n* Serum AST, ALT, and alkaline phosphatase ≤ 2 times upper limit of normal (ULN)\n* Total bilirubin normal\n* Creatinine clearance \\> 50 mL/min\n* Negative pregnancy test\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during study and for 30 days after the last study drug administration\n* No serious, uncontrolled, concurrent infection(s)\n* No diabetes with current or history of delayed wound healing or skin ulcers\n* No autoimmune connective tissue disorder\n* No prior unanticipated severe reaction to fluoropyrimidine therapy, known sensitivity to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency\n* No other carcinomas within the last five years except cured non-melanoma skin cancer and in-situ cervical cancer\n* No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months\n* No other serious uncontrolled medical conditions that the investigator feels might compromise study participation, including any of the following:\n\n * Uncontrolled seizures\n * Psychiatric disability judged by the investigator to be clinically significant\n* Physically intact upper gastrointestinal tract\n* No malabsorption syndrome\n* No uncompensated coagulopathy\n* No patients whose breast size or body contour puts them at increased risk for skin desquamation from standard radiotherapy\n* Able to read and speak English\n\nPRIOR CONCURRENT THERAPY:\n\n* Fully recovered from surgery and chemotherapy with completely healed surgical wounds\n* At least 4 weeks since completion of prior chemotherapy regimen, excluding trastuzumab (Herceptin®)\n\n * Concurrent trastuzumab allowed at the physician's discretion\n* More than 4 weeks since prior participation in any investigational drug study\n* At least 4 weeks since prior and no concurrent sorivudine or brivudine\n* More than 2 weeks since prior major surgery\n* No prior capecitabine\n* No prior radiotherapy to the chest or ipsilateral lymphatics\n* No concurrent hormonal therapy during course of chemotherapy or radiation therapy\n* No concurrent allopurinol or cimetidine\n* Concurrent coumadin is allowed"}, 'identificationModule': {'nctId': 'NCT00562718', 'briefTitle': 'Capecitabine and Radiation Therapy in Treating Patients With Nonmetastatic Breast Cancer After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'A Pilot Safety And Feasibility Study Of Concurrent Capecitabine (Xeloda) And External Beam Irradiation In The Adjuvant Treatment Of High Risk Early Stage Breast Cancer.', 'orgStudyIdInfo': {'id': 'CDR0000574761'}, 'secondaryIdInfos': [{'id': 'SCCC-072004-004'}, {'id': 'ROCHE-SCCC-072004-004'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgery and Chemotherapy', 'description': 'Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.', 'interventionNames': ['Drug: capecitabine', 'Procedure: adjuvant therapy', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'capecitabine', 'type': 'DRUG', 'armGroupLabels': ['Surgery and Chemotherapy']}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE', 'armGroupLabels': ['Surgery and Chemotherapy']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['Surgery and Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Dan P. Garwood, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Simmons Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}