Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-26 @ 8:24 PM
Study NCT ID:
NCT00010166
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2001-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2003-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2001-02-02', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-10-03', 'type': 'ACTUAL'}}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stage I pancreatic cancer', 'adenocarcinoma of the pancreas'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '16868545', 'type': 'RESULT', 'citation': 'Blackstock AW, Mornex F, Partensky C, Descos L, Case LD, Melin SA, Levine EA, Mishra G, Limentani SA, Kachnic LA, Tepper JE. Adjuvant gemcitabine and concurrent radiation for patients with resected pancreatic cancer: a phase II study. Br J Cancer. 2006 Aug 7;95(3):260-5. doi: 10.1038/sj.bjc.6603270. Epub 2006 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gemcitabine may make tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy after surgery may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with radiation therapy in treating patients who have undergone surgery to remove cancer of the pancreas.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the time to disease progression, local control, and survival of patients with previously resected pancreatic cancer treated with adjuvant gemcitabine and radiotherapy.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 in the absence of disease progression or unacceptable toxicity.\n\nBeginning at least 4 weeks after chemoradiotherapy, patients without disease progression and with less than 10% weight loss during study receive additional gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.\n\nPatients are followed every 8 weeks for 6 months and then every 3 months for up to 2 years.\n\nPROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 2.2 or 3.4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed invasive adenocarcinoma of the pancreas\n\n * Prior gross total resection via a pancreaticoduodenectomy (Whipple resection or total pancreatectomy) within the past 2 months\n* No clinical evidence of gross residual disease at time of surgery\n\n * No focally positive margins (tumor at the margin)\n* No unresected nodal disease or metastatic disease to the liver, peritoneal surfaces, or elsewhere\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 18\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* More than 6 months\n\nHematopoietic:\n\n* Granulocyte count greater than 1,500/mm3\n* Hemoglobin greater than 10 g/dL\n* Platelet count greater than 100,000/mm3\n\nHepatic:\n\n* Bilirubin less than 2.0 mg/dL\n\nRenal:\n\n* Creatinine less than 2.0 mg/dL\n\nOther:\n\n* Able to maintain adequate oral nutrition\n* Documented stable weight (no more than 5 lbs weight loss) for at least 2 weeks prior to study\n* No other malignancy within the past 2 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast\n* Non-metastatic prostate cancer allowed if more than 2 year survival likely\n* No other serious medical or psychiatric illness that would preclude study or limit survival to less than 2 years\n* Not pregnant\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent routine growth factors\n\nChemotherapy:\n\n* No prior chemotherapy for pancreatic cancer\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior abdominal radiotherapy for pancreatic cancer\n\nSurgery:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00010166', 'briefTitle': 'Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': "Phase II Trial Of Adjuvant 2'2'-Difluoro-2'-Deoxycytidine (Gemcitabine) And External Beam Radiation For The Treatment Of Resectable Pancreatic Cancer", 'orgStudyIdInfo': {'id': 'REBACDR0000068452'}, 'secondaryIdInfos': [{'id': 'CCCWFU-57198'}, {'id': 'NCI-104'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gemcitabine hydrochloride', 'type': 'DRUG'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157-1082', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Arthur William Blackstock, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}