Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
Study NCT ID:
NCT00023660
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2001-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'lastUpdateSubmitDate': '2013-11-18', 'studyFirstSubmitDate': '2001-09-13', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage III cervical cancer', 'stage IB cervical cancer', 'stage IIB cervical cancer', 'stage IIA cervical cancer', 'stage IVA cervical cancer', 'cervical squamous cell carcinoma', 'cervical adenocarcinoma', 'cervical adenosquamous cell carcinoma'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '22193645', 'type': 'BACKGROUND', 'citation': 'Viswanathan AN, Moughan J, Small W Jr, Levenback C, Iyer R, Hymes S, Dicker AP, Miller B, Erickson B, Gaffney DK. The quality of cervical cancer brachytherapy implantation and the impact on local recurrence and disease-free survival in radiation therapy oncology group prospective trials 0116 and 0128. Int J Gynecol Cancer. 2012 Jan;22(1):123-31. doi: 10.1097/IGC.0b013e31823ae3c9.'}, {'pmid': '19509178', 'type': 'RESULT', 'citation': 'Weidhaas JB, Li SX, Winter K, Ryu J, Jhingran A, Miller B, Dicker AP, Gaffney D. Changes in gene expression predicting local control in cervical cancer: results from Radiation Therapy Oncology Group 0128. Clin Cancer Res. 2009 Jun 15;15(12):4199-206. doi: 10.1158/1078-0432.CCR-08-2257. Epub 2009 Jun 9.'}, {'pmid': '18299147', 'type': 'RESULT', 'citation': 'Zempolich K, Fuhrman C, Milash B, Flinner R, Greven K, Ryu J, Forbes A, Kerlin K, Nichols RC, Gaffney DK. Changes in gene expression induced by chemoradiation in advanced cervical carcinoma: a microarray study of RTOG C-0128. Gynecol Oncol. 2008 May;109(2):275-9. doi: 10.1016/j.ygyno.2008.01.027. Epub 2008 Mar 4.'}, {'pmid': '17084549', 'type': 'RESULT', 'citation': 'Gaffney DK, Winter K, Dicker AP, Miller B, Eifel PJ, Ryu J, Avizonis V, Fromm M, Greven K. A Phase II study of acute toxicity for Celebrex (celecoxib) and chemoradiation in patients with locally advanced cervical cancer: primary endpoint analysis of RTOG 0128. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):104-9. doi: 10.1016/j.ijrobp.2006.08.002. Epub 2006 Nov 2.'}, {'pmid': '17482376', 'type': 'RESULT', 'citation': 'Gaffney DK, Winter K, Dicker AP, Miller B, Eifel PJ, Ryu J, Avizonis V, Fromm M, Small W, Greven K. Efficacy and patterns of failure for locally advanced cancer of the cervix treated with celebrex (celecoxib) and chemoradiotherapy in RTOG 0128. Int J Radiat Oncol Biol Phys. 2007 Sep 1;69(1):111-7. doi: 10.1016/j.ijrobp.2007.02.050. Epub 2007 May 4.'}, {'pmid': '15863167', 'type': 'RESULT', 'citation': 'Gaffney DK, Winter K, Fuhrman C, Flinner R, Greven K, Ryu J, Forbes A, Kerlin K, Nichols RC, Zempolich K. Feasibility of RNA collection for micro-array gene expression analysis in the treatment of cervical carcinoma: a scientific correlate of RTOG C-0128. Gynecol Oncol. 2005 May;97(2):607-11. doi: 10.1016/j.ygyno.2005.01.014.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy in different ways and combining it with chemotherapy may kill more tumor cells. Celecoxib may slow the growth of cervical cancer by stopping blood flow to the tumor.\n\nPURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus celecoxib, fluorouracil, and cisplatin in treating patients who have locally advanced cervical cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine treatment-related toxicity rates in patients with locally advanced cervical cancer treated with external beam radiotherapy and brachytherapy concurrently with celecoxib, fluorouracil, and cisplatin.\n* Determine whether this regimen increases locoregional control rates, distant control, disease-free survival, and overall survival in these patients.\n* Determine whether first-failure patterns in patients treated with this regimen are changed compared to historical controls.\n\nOUTLINE: This is a multicenter study.\n\nPatients undergo external beam pelvic radiotherapy once daily five days a weeks for 5 weeks beginning on day 1. Within 8 weeks, patients undergo low-dose or high-dose brachytherapy. Patients also receive concurrent chemotherapy comprising fluorouracil IV continuously over days 2-5, 23-26, and 44-47 and cisplatin IV over 4 hours on days 1, 22, and 43. Oral celecoxib is administered twice daily beginning on day 1 and continuing for 12 months.\n\nPatients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1.5 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed squamous, adenocarcinoma, or adenosquamous carcinoma of the cervix\n\n * Stage IIB-IVA OR\n * Stage IB-IIA with pelvic node metastases and/or tumor size at least 5 cm\n* No small cell, carcinoid, glassy cell, clear cell, or adenoid cystic disease\n* No metastatic disease outside of pelvis\n* No para-aortic disease\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 85\n\nPerformance status:\n\n* Zubrod 0-2\n\nLife expectancy:\n\n* At least 6 months\n\nHematopoietic:\n\n* WBC at least 3,000/mm\\^3\n* Absolute granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n* AST or ALT no greater than 2.5 times upper limit of normal (ULN)\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n* Creatinine clearance at least 50 mL/min\n* Calcium no greater than 1.3 times ULN\n\nCardiovascular:\n\n* No severe heart disease\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* HIV negative\n* No prior allergy to sulfonamides or non-steroidal anti-inflammatory drugs (NSAIDs)\n* No prior hypersensitivity to celecoxib or any component of its formulation\n* No medical or psychiatric illness that would preclude study\n* No active gastrointestinal (GI) ulcer, GI bleeding, or inflammatory bowel disease\n* No other prior malignancy within the past 5 years except cutaneous basal cell skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No recent prior celecoxib or other cyclo-oxygenase-2 inhibitor\n\nChemotherapy:\n\n* No prior systemic chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiotherapy to pelvis except transvaginal radiotherapy to control bleeding\n\nSurgery:\n\n* No prior surgery for cervical cancer except biopsy\n\nOther:\n\n* No concurrent phenytoin or lithium\n* No other concurrent NSAIDs'}, 'identificationModule': {'nctId': 'NCT00023660', 'briefTitle': 'Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Radiation Therapy Oncology Group'}, 'officialTitle': 'A Phase I/II Study Of COX-2 Inhibitor, CELEBREX (CELECOXIB), And Chemoradiation In Patients With Locally Advanced Cervical Cancer', 'orgStudyIdInfo': {'id': 'RTOG-C-0128'}, 'secondaryIdInfos': [{'id': 'CDR0000068849'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'celecoxib', 'type': 'DRUG'}, {'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'brachytherapy', 'type': 'RADIATION'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36652-2144', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Infirmary Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Foundation for Cancer Research and Education', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94010', 'city': 'Burlingame', 'state': 'California', 'country': 'United States', 'facility': 'Mills-Peninsula Health Services', 'geoPoint': {'lat': 37.5841, 'lon': -122.36608}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Health Western Division Cancer Research Group', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '94143-0128', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Memorial Hospital Cancer Center', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33256-2110', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Hospital of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30165', 'city': 'Rome', 'state': 'Georgia', 'country': 'United States', 'facility': 'Regional Radiation Oncology Center at Rome', 'geoPoint': {'lat': 34.25704, 'lon': -85.16467}}, {'zip': '61636', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Methodist Medical Center of Illinois', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '47303-3499', 'city': 'Muncie', 'state': 'Indiana', 'country': 'United States', 'facility': 'Ball Memorial Hospital Cancer Center', 'geoPoint': {'lat': 40.19338, 'lon': -85.38636}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'West Michigan Cancer Center', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'CCOP - Kansas City', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68114-4199', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'CCOP - Southern Nevada Cancer Research Foundation', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07740-6395', 'city': 'Long Branch', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Monmouth Medical Center', 'geoPoint': {'lat': 40.30428, 'lon': -73.99236}}, {'zip': '08332', 'city': 'Millville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'South Jersey Regional Cancer Center', 'geoPoint': {'lat': 39.40206, 'lon': -75.03934}}, {'zip': '08060', 'city': 'Mount Holly', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital', 'geoPoint': {'lat': 39.99289, 'lon': -74.78766}}, {'zip': '07112', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Newark Beth Israel Medical Center', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Community Medical Center', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York Health Science Center at Brooklyn', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'New York Methodist Hospital', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '27157-1065', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44302', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Akron General Medical Center', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '44304', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Akron City Hospital - Summa Health System', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '19010', 'city': 'Bryn Mawr', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bryn Mawr Hospital', 'geoPoint': {'lat': 40.30396, 'lon': -80.08672}}, {'zip': '19023', 'city': 'Darby', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mercy Fitzgerald Hospital', 'geoPoint': {'lat': 39.91845, 'lon': -75.25907}}, {'zip': '19026', 'city': 'Drexel Hill', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Delaware County Memorial Hospital', 'geoPoint': {'lat': 39.94706, 'lon': -75.29213}}, {'zip': '19301-1792', 'city': 'Paoli', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Paoli Memorial Hospital', 'geoPoint': {'lat': 40.04205, 'lon': -75.47631}}, {'zip': '19107-5097', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Kimmel Cancer Center at Thomas Jefferson University - Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Pennsylvania Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CCOP - MainLine Health', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lankenau Cancer Center at Lankenau Hospital', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84143', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'LDS Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84770', 'city': 'St. George', 'state': 'Utah', 'country': 'United States', 'facility': 'Dixie Regional Medical Center', 'geoPoint': {'lat': 37.10415, 'lon': -113.58412}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'CCOP - Marshfield Clinic Research Foundation', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}], 'overallOfficials': [{'name': 'David K. Gaffney, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radiation Therapy Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}