Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-02 @ 9:02 AM
Study NCT ID:
NCT00878657
Status:
TERMINATED
Last Update Posted:
2014-05-05
First Post:
2009-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensity-Modulated Radiation Therapy and Gemcitabine in Treating Patients With Locally Advanced Pancreatic Cancer
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': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], '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': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-01', 'studyFirstSubmitDate': '2009-04-08', 'studyFirstSubmitQcDate': '2009-04-08', 'lastUpdatePostDateStruct': {'date': '2014-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose of intensity-modulated radiotherapy (Phase I)', 'timeFrame': '4 years'}, {'measure': 'Overall survival (Phase II)', 'timeFrame': '4 years'}, {'measure': 'Disease-free survival (Phase II)', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenocarcinoma of the pancreas', 'stage III pancreatic cancer'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy together with gemcitabine may kill more tumor cells.\n\nPURPOSE: This phase I/II trial is studying the side effects and best dose of intensity-modulated radiation therapy and to see how well it works when given together with gemcitabine in treating patients with locally advanced pancreatic cancer.', 'detailedDescription': 'The study was terminated early due to slow accrual and only the phase I portion of hte study was opened. The phase of the study has been revised to only a phase I study.\n\nOBJECTIVES:\n\n* To determine the maximum tolerated dose (MTD) of intensity-modulated radiotherapy delivered to the gross tumor volume when administered with gemcitabine hydrochloride in patients with locally advanced pancreatic carcinoma. (Phase I)\n* To define the dose-limiting toxicities of this regimen in these patients. (Phase I)\n* To determine the local control in patients treated at the MTD (determined in phase I). (Phase II)\n* To compare the disease-free survival and time to progression in these patients with that of historical controls. (Phase II)\n\nOUTLINE: This is a multicenter phase I, dose-escalation study of intensity-modulated radiotherapy, followed by a phase II study.\n\n* Induction chemotherapy: Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo CT scan. Patients with no evidence of metastatic disease proceed to chemoradiotherapy.\n* Chemoradiotherapy: Beginning 1-2 weeks after completion of induction chemotherapy, patients undergo intensity-modulated radiotherapy once daily 5 days a week and gemcitabine hydrochloride IV over 30 minutes once weekly for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients whose disease remains unresectable proceed to adjuvant chemotherapy.\n* Adjuvant chemotherapy: Beginning 4-6 weeks after completion of chemoradiotherapy, patients receive gemcitabine hydrochloride as in induction chemotherapy.\n\nAfter completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Pathologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas, ampulla of Vater, or distal bile duct\n\n * Locally advanced disease\n * Medically inoperable, unresectable, or borderline resectable disease\n\n * No previously resected disease (i.e., status post-pancreaticoduodenotomy)\n* No non-adenocarcinoma, adenosquamous carcinoma, islet cell carcinoma, cyst adenoma, cystadenocarcinoma, carcinoid tumor, or duodenal carcinoma\n* No lesions in the tail of the pancreas and/or splenic artery/vein involvement/encasement\n* No recurrent or metastatic (M1) disease\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 60-100%\n* WBC \\> 3,000/μL\n* Platelet count \\> 100,000/μL\n* Bilirubin ≤ 2 mg/dL\n* SGOT \\< 5 times upper limit of normal (ULN)\n* Creatinine \\< 1.5 times ULN\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Adequate oral nutrition (e.g., ≥ 1,500 calories/day, stable weight for ≥ 2 weeks, and ≤ 5% weight loss)\n* No active malignancy within the past 3 years, except cervical carcinoma in situ or nonmelanoma skin cancer that has been removed\n* No severe, active comorbidity, including any of the following:\n\n * Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months\n * Transmural myocardial infarction within the past 6 months\n * Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration\n * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within the past month or precluding study therapy at the time of study registration\n * Active hepatitis, decompensated cirrhosis, or clinically significant liver failure\n * Other severe comorbid condition, as determined by the principal investigator\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior chemotherapy\n* No prior radiotherapy to any upper abdominal site\n* No concurrent prophylactic colony-stimulating factors during radiotherapy\n* No concurrent warfarin\n* No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, surgery for cancer, or experimental therapy'}, 'identificationModule': {'nctId': 'NCT00878657', 'briefTitle': 'Intensity-Modulated Radiation Therapy and Gemcitabine in Treating Patients With Locally Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Phase I/II Radiotherapy Dose Escalation Study in Locally Advanced Pancreatic Cancer, Using a Simultaneous Intensity Modulated Boost With Concurrent Gemcitabine', 'orgStudyIdInfo': {'id': 'CDR0000639635'}, 'secondaryIdInfos': [{'id': 'P30CA072720', 'link': 'https://reporter.nih.gov/quickSearch/P30CA072720', 'type': 'NIH'}, {'id': 'CINJ-070805', 'type': 'OTHER', 'domain': 'Rutgers Cancer Institute of New Jersey'}, {'id': '0220090024', 'type': 'OTHER', 'domain': 'The Rutgers RBHS Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiotherapy plus gemcitabine', 'description': 'Drug: gemcitabine hydrochloride\n\nRadiation: intensity-modulated radiation therapy', 'interventionNames': ['Drug: gemcitabine hydrochloride', 'Radiation: intensity-modulated radiation therapy']}], 'interventions': [{'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'description': 'Pre-Chemoradiation (Induction) Chemotherapy Gemcitabine will be given weekly for seven doses at a dose of 1000 mg/m2/wk (Days 1, 8, 15, 22, 29, 36, 43) unless toxicity develops. Chemoradiation gemcitabine will be given 400 mg/m2, infused over 30 minutes, within 120 minutes before radiotherapy. Post-chemoradiation chemotherapy, patients will receive two cycles of gemcitabine. A cycle will be defined as three weeks of gemcitabine at 1000 mg/m2/d, once weekly, followed by a one-week rest.', 'armGroupLabels': ['Radiotherapy plus gemcitabine']}, {'name': 'intensity-modulated radiation therapy', 'type': 'RADIATION', 'description': 'Dose escalation levels (cohorts) for this study:\n\nDose Level 1: GTV plus drainage areas 45 Gy, Boost GTV 50.4 Gy Dose Level 2: GTV plus drainage areas 45 Gy, Boost GTV 54.0 Gy Dose Level 3: GTV plus drainage areas 45 Gy, Boost GTV 59.4 Gy Dose Level 4: GTV plus drainage areas 45 Gy, Boost GTV 64.8 Gy Dose Level 5: GTV plus drainage areas 45 Gy, Boost GTV 70.2 Gy', 'armGroupLabels': ['Radiotherapy plus gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Salma Jabbour, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers Cancer Institute of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}