Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT00006256
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2000-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2000-09-11', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the feasibility of concurrent paclitaxel and breast radiotherapy', 'timeFrame': 'Followed every 3 months for 1 year', 'description': 'Ability to deliver appropriate doses of radiation therapy within the appropriate time course'}, {'measure': 'chemotherapy dose achieved during concurrent Taxol and radiation therapy.', 'timeFrame': 'Followed every 3 months for 1 year'}], 'secondaryOutcomes': [{'measure': 'Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor.', 'timeFrame': '1 year', 'description': 'These parameters will be assessed by medical and radiation oncology. We expect at least a \\> 60% completion rate with this treatment, which translates into confidence limits of 46% to 74% when 40 patients are investigated.'}, {'measure': 'Pulmonary function', 'timeFrame': '1 year', 'description': 'Combined treatment impact on pulmonary function. Evidence of pulmonary toxicity demonstrated by a reduction in DLCO (Diffusing Capacity of the Lung for Carbon Monoxide).'}, {'measure': 'Survival', 'timeFrame': '5 years', 'description': 'Patients followed for long term survival for at least 5 years.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining paclitaxel with radiation therapy may kill more tumor cells.\n\nPURPOSE: This trial is to study the effectiveness of concurrent administration of chemotherapy and radiation therapy in treating women who have stage II or stage III breast cancer by examining the complications and cosmetic effects.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the feasibility of concurrent paclitaxel and breast radiotherapy in women with stage II or III breast cancer who have had primary breast conserving surgery and adjuvant chemotherapy.\n* Assess the cosmetic results of breast conservation after this treatment in these patients.\n* Determine the pulmonary toxicity of this regimen in these patients.\n\nOUTLINE: Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen. Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed at 1 month, every 3 months for 1 year, every 6 months for the next 5 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study over 12-18 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Stage II or III invasive breast cancer\n* Prior breast conserving surgery (lumpectomy or quadrantectomy) with ipsilateral axillary lymph node dissection required\n* No prior contralateral breast cancer\n* No metastatic disease\n* Prior ductal carcinoma in situ or lobular carcinoma in situ of the breast allowed unless treated with radiation or chemotherapy\n* Doxorubicin and cyclophosphamide adjuvant chemotherapy completed within past 3 weeks\n* Candidate for definitive radiotherapy\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* ECOG 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC at least 3,000/mm3\n* Granulocyte count at least 2,000/mm3\n* Platelet count at least 100,000/mm3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* ALT/AST no greater than 1.5 times ULN\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n\nCardiovascular:\n\n* No concurrent poorly controlled ischemic heart disease or congestive heart failure\n* LVEF at least 45% by MUGA scan or echocardiogram\n\nPulmonary:\n\n* No concurrent severe chronic obstructive or restrictive pulmonary disease\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No concurrent severe medical or psychiatric illness\n* No concurrent severe diabetes mellitus\n* No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix treated with local excision\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent filgrastim (G-CSF)\n\nChemotherapy:\n\n* See Disease Characteristics\n* Prior tamoxifen allowed\n* No concurrent tamoxifen\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiation to the breast\n\nSurgery:\n\n* Recovered form prior surgery\n\nOther:\n\n* No concurrent adjuvant therapy on another clinical trial'}, 'identificationModule': {'nctId': 'NCT00006256', 'briefTitle': 'Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy', 'orgStudyIdInfo': {'id': 'CWRU2199'}}, 'armsInterventionsModule': {'interventions': [{'name': 'paclitaxel', 'type': 'DRUG', 'description': 'Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen.'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE', 'description': 'doxorubicin and cyclophosphamide adjuvant regimen'}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44708', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH-CantonMercy', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '44024', 'city': 'Chardon', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH-Geauga', 'geoPoint': {'lat': 41.61422, 'lon': -81.14899}}, {'zip': '44106-5055', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44124', 'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH-Monarch', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH-LUICC', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH-Southwest', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '44122', 'city': 'Orange', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH-Chagrin Highlands', 'geoPoint': {'lat': 41.44978, 'lon': -81.48067}}, {'zip': '44121', 'city': 'South Euclid', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH-Green Road', 'geoPoint': {'lat': 41.52311, 'lon': -81.51846}}, {'zip': '44145', 'city': 'Westlake', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH-Westlake', 'geoPoint': {'lat': 41.45532, 'lon': -81.91792}}], 'overallOfficials': [{'name': 'Janice Lyons, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}